Klinisk forsøg for Parkinsons sygdom ved hjælp af allogene HB-adMSC'er (tidlig og moderat PD)
Et randomiseret, dobbeltblindt, enkelt center, fase 2, effektivitet og sikkerhedsundersøgelse af allogene HB-adMSC'er vs placebo til behandling af patienter med Parkinsons sygdom
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Forsøget omfatter en screeningsperiode på op til 4 uger, en 32-ugers behandlingsperiode og en sikkerhedsopfølgningsperiode på 20 uger efter den sidste forsøgsproduktadministration.
Dette kliniske forsøg vil være åbent for at tilmelde 60 kvalificerede deltagere diagnosticeret med Parkinsons sygdom. Patienternes rekruttering vil blive udført af undersøgelsesteamet, hvis kvalificerede deltagere identificeres ud fra berettigelseskriterier, vil der blive planlagt et screeningsbesøg. Formularen til informeret samtykke vil blive givet til undersøgelsens deltagere og underskrevet før eventuelle undersøgelsesprocedurer. Formularen til informeret samtykke vil indeholde oplysninger om det kliniske forsøg, og nogle aspekter bør overvejes under denne proces.
Efter informeret samtykke er opnået, skal hver deltager gennemføre følgende besøg.
- Besøg 1 - Screening, under dette besøg vil hovedinvestigatoren træffe beslutningen om, hvorvidt den screenede deltager er kvalificeret, og om det næste besøg kan planlægges. Når den primære investigator har vurderet egnetheden af den screenede forsøgsperson (op til 28 dage), vil der blive udført en randomiseringsproces for at tildele den kvalificerede forsøgsperson enten allogene HB-adMSC'er eller placebo. Randomisering vil kun gælde for berettigede fag. Hvis en undersøgelsesdeltager ikke opfylder inklusions- og eksklusionskriterierne under screeningsprocessen, vil han/hun blive betragtet som Screen Failure (SF), og randomisering er ikke påkrævet.
- Besøg 2 - Infusion 1, (Baseline): dette besøg vil blive brugt som udgangspunkt for sammenligning af deltagerens data. Under dette besøg vil kvalificerede undersøgelsesdeltagere modtage sin første forsøgsproduktadministration eller placebo med overvågning af vitale tegn i i alt 2 timer efter lægemiddeleksponering. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Besøg 3 - Infusion 2: ca. 4 uger efter den indledende forsøgsproduktadministration bør dette besøg afsluttes. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Besøg 4 - Infusion 3: ca. 8 uger efter den indledende forsøgsproduktadministration bør dette besøg afsluttes. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Besøg 5 - Infusion 4: ca. 12 uger efter den indledende forsøgsproduktadministration bør dette besøg afsluttes. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Besøg 6 - Infusion 5: ca. 16 uger efter den indledende forsøgsproduktadministration bør dette besøg afsluttes. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Besøg 7 - Infusion 6: ca. 20 uger efter den indledende forsøgsproduktadministration bør dette besøg afsluttes. Andre undersøgelsesevalueringer vil blive afsluttet som en del af dette besøg.
- Telefonopkald - Sikkerhedsopfølgning: cirka 24 uger efter den indledende undersøgelsesproduktadministration vil aktive undersøgelsesdeltagere gennemføre en telefonopkaldsopfølgning.
- Telefonopkald - Sikkerhedsopfølgning: cirka 32 uger efter den indledende undersøgelsesproduktadministration vil aktive undersøgelsesdeltagere gennemføre en telefonopkaldsopfølgning.
- Besøg 8 - Afslutning af undersøgelsen, under dette sidste besøg (ca. 52 uger efter uge 0) vil en komplet gruppe af undersøgelsesvurderinger blive udført for at evaluere sikkerheden og effektiviteten af allogene HB-adMSC'er eller placebo-administrationer.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Texas
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Sugar Land, Texas, Forenede Stater, 77478
- Hope Biosciences Stem Cell Research Foundation
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
En undersøgelsesdeltager vil kun være berettiget til at blive inkluderet i denne undersøgelse, hvis alle følgende kriterier gælder:
- Mandlige og kvindelige deltagere 45 - 80 år.
- Ved screeningsbesøget skal undersøgelsens deltagere have en MDS-UPDRS del II-score mellem 7 og 28.
- Undersøgelsesdeltagere skal have en MDS-UPDRS del III-score mellem 20 og 57 under screeningsbesøget.
- Den samlede dosis Carbidopa/Levodopa skal være mindre end 1200 mg dagligt for forsøgsdeltagere.
- Den samlede Levodopa-ækvivalente dosis for forsøgsdeltagere skal være mindre end 1400 mg pr. dag.
- Studiedeltageren skal have været diagnosticeret med tidlig og/eller moderat Parkinsons sygdom mindst 2 år forud for deltagelse i undersøgelsen.
- Studiedeltagere skal kunne læse, forstå og give skriftligt samtykke.
- Frivilligt underskrevet informeret samtykke opnået, før der udføres kliniske forsøgsrelaterede procedurer.
- Kvindelige forsøgsdeltagere bør ikke være gravide eller planlægge at blive gravide under undersøgelsesdeltagelsen og i 6 måneder efter sidste forsøgsproduktadministration.
- Mandlige deltagere, hvis deres seksuelle partnere kan blive gravide, bør bruge en præventionsmetode under undersøgelsesdeltagelsen og i 6 måneder efter den sidste administration af det undersøgte produkt.
- Studiedeltageren er i stand til og villig til at overholde kravene i dette kliniske forsøg.
Ekskluderingskriterier:
En undersøgelsesdeltager vil ikke være berettiget til at blive inkluderet i dette kliniske forsøg, hvis et af følgende kriterier gælder:
- Graviditet, amning. Kvinder i den fødedygtige alder, som ikke er gravide, men som ikke tager effektive præventionsforanstaltninger.
- Studiedeltagere med fremskreden Parkinsons sygdom beskrevet som alvorligt handicap, kørestolsbundet eller sengeliggende.
- Undersøgelsesdeltageren har enhver aktiv malignitet, inklusive tegn på kutant basal-, pladecelle- eller melanom.
- Undersøgelsesdeltageren har kendt alkoholafhængighed eller afhængighed eller har aktuelt stofbrug eller misbrug.
Studiedeltageren har 1 eller flere væsentlige samtidige medicinske tilstande (verificeret af lægejournaler), herunder følgende:
- Dårligt kontrolleret diabetes mellitus (PCDM) defineret som historie med mangelfuld standardbehandling og/eller præ-prandial glukose >130 mg/dl under screeningsbesøg eller post-prandial glukose >200 mg/dl.
- Sygehistorie med diagnose af kronisk nyresygdom (CKD) og/eller screeningsresultater af eGFR < 59 ml/min/1,73 m2.
- Tilstedeværelse af New York Heart Association (NYHA) klasse III/IV hjertesvigt under screeningsbesøg.
- Enhver sygehistorie med myokardieinfarkt i en af de forskellige typer, såsom ST-elevation myokardieinfarkt (STEMI) eller ikke-ST-forhøjet myokardieinfarkt (NSTEMI), koronar spasmer eller ustabil angina.
- Sygehistorie med ukontrolleret højt blodtryk defineret som en mangelfuld standardbehandling og/eller blodtryk > 180/120 mm/Hg under screeningsbesøg.
- Sygehistorie med arvelige trombofilier, nylig større generel operation, (inden for 12 måneder før screeningen), lammelse af nedre ekstremiteter på grund af rygmarvsskade, brud på bækken, hofter eller lårben, kræft i lunge, hjerne, lymfe, gynækologisk system ( æggestok eller livmoder), eller mave-tarmkanalen (som bugspytkirtel eller mave).
- Historie om hjernekirurgi for Parkinsons sygdom.
- Studiedeltageren har modtaget enhver stamcellebehandling inden for 6 måneder før den første dosis af forsøgsproduktet, bortset fra stamceller produceret af Hope Biosciences.
- Modtagelse af enhver forsøgsbehandling eller enhver godkendt terapi til forsøgsbrug inden for 1 år forud for første dosis af forsøgsproduktet, bortset fra COVID-19-vacciner.
Studiedeltageren har en laboratorieabnormitet under screening, herunder følgende:
- Antal hvide blodlegemer < 3000/mm3
- Blodpladetal < 80.000 mm3
- Absolut neutrofiltal < 1500/mm3
- Alaninaminotransferase (ALT) eller aspartataminotransferase (AST) 10 øvre normalgrænse (ULN) x 1,5
- Studiedeltageren har enhver anden laboratorieabnormitet eller medicinsk tilstand, som efter investigatorens mening udgør en sikkerhedsrisiko eller vil forhindre forsøgspersonen i at gennemføre undersøgelsen.
- Det er usandsynligt, at undersøgelsesdeltageren vil gennemføre undersøgelsen eller overholde undersøgelsesprocedurerne.
- Studiedeltager med kendt samtidig akut eller kronisk viral hepatis B eller C eller human immundefektvirus (HIV) infektion.
- Studiedeltageren har en tidligere diagnosticeret psykiatrisk tilstand, som efter undersøgerens vurdering kan påvirke egenvurderinger.
- Undersøgelsesdeltager med enhver systemisk infektion, der kræver behandling med antibiotika, antivirale eller antifungale midler inden for 30 dage før første dosis af forsøgsproduktet.
- Mandlige forsøgsdeltagere, der planlægger at donere sæd under undersøgelsen eller inden for 6 måneder efter den sidste dosis. Kvindelige patienter, der planlægger at donere æg eller gennemgå in vitro fertiliseringsbehandling under undersøgelsen eller inden for 6 måneder efter den sidste dosis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Allogene HB-adMSC'er.
Biologisk/vaccine: Allogene HB-adMSC'er Allogene HB-adMSC'er vil blive administreret intravenøst til studiedeltagere, der kvalificerer sig. Andre navne: Allogeneic Hope Biosciences fedtafledte mesenkymale stamceller. |
HB-adMSC'er vil blive administreret intravenøst til studiedeltagere, der kvalificerer sig.
Andre navne:
Steril saltvandsopløsning 0,9 %
Andre navne:
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Placebo komparator: Placebo
Placebo vil blive administreret intravenøst til undersøgelsesdeltagere, der kvalificerer sig. Andre navne: Steril saltvandsopløsning 0,9 % |
HB-adMSC'er vil blive administreret intravenøst til studiedeltagere, der kvalificerer sig.
Andre navne:
Steril saltvandsopløsning 0,9 %
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
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Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The MDS-UPDRS scale consists of 4 segments.
Part II tests "Motor Aspects of Experiences of Daily Living".
Each answer to the scale is evaluated by the principal investigator during the study visit.
Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.
There are 13 items included in Part II.
Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe.
Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Tidsramme: Baseline to Weeks 52
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The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Tidsramme: Baseline to Weeks 52
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Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
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Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Tidsramme: Baseline to Weeks 52
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The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Tidsramme: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Tidsramme: Baseline to Weeks 52
|
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section.
The total score is achieved by summing the two individual scores.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Summary of PD Medication Dose Changes by Visit
Tidsramme: Baseline to Weeks 52
|
The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
|
Summary of PD Medication Reinstatement by Visit
Tidsramme: Baseline to Weeks 52
|
The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
|
Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
Tidsramme: Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
Tidsramme: Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (mL/min/1.73
m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Tidsramme: Baseline to Weeks 52
|
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Weight - kg)
Tidsramme: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Abdomen
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Cardiovascular
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - HEENT
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Lymph Node
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Neurological
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Respiratory
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Skin
Tidsramme: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation
Publikationer og nyttige links
Generelle publikationer
- Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
- Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
- Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
- Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
- Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
- Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
- Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
- Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
- Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
- Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
- Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HBPD04
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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produkt fremstillet i og eksporteret fra U.S.A.
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