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Klinische Studie zur Parkinson-Krankheit mit allogenen HB-adMSCs (frühe und mittelschwere PD)

14. Mai 2026 aktualisiert von: Hope Biosciences Research Foundation

Eine randomisierte, doppelblinde, monozentrische Phase-2-Studie zur Wirksamkeit und Sicherheit von allogenen HB-adMSCs im Vergleich zu Placebo zur Behandlung von Patienten mit Parkinson-Krankheit

Dies ist eine randomisierte, doppelblinde, monozentrische Phase-2-Studie zur Bewertung der Wirksamkeit und Sicherheit von multiplen allogenen HB-adMSCs im Vergleich zu Placebo zur Behandlung der Parkinson-Krankheit.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Die Studie umfasst einen Screening-Zeitraum von bis zu 4 Wochen, einen 32-wöchigen Behandlungszeitraum und einen Sicherheits-Follow-up-Zeitraum von 20 Wochen nach der letzten Verabreichung des Prüfpräparats.

In diese klinische Studie können 60 geeignete Teilnehmer aufgenommen werden, bei denen die Parkinson-Krankheit diagnostiziert wurde. Die Patientenrekrutierung wird vom Studienteam durchgeführt, wenn geeignete Teilnehmer anhand der Eignungskriterien identifiziert werden, wird ein Screening-Besuch angesetzt. Eine Einwilligungserklärung wird den Studienteilnehmern ausgehändigt und vor allen Studienverfahren unterzeichnet. Die Einverständniserklärung enthält Informationen über die klinische Studie, und einige Aspekte sollten während dieses Prozesses berücksichtigt werden.

Nachdem die Einverständniserklärung eingeholt wurde, sollte jeder Teilnehmer die folgenden Besuche absolvieren.

  • Besuch 1 – Screening, während dieses Besuchs trifft der Hauptforscher die Entscheidung, ob der gescreente Teilnehmer geeignet ist und ob der nächste Besuch geplant werden kann. Sobald der Hauptprüfarzt die Eignung des gescreenten Probanden bewertet hat (bis zu 28 Tage), wird ein Randomisierungsprozess durchgeführt, um dem geeigneten Probanden entweder allogene HB-adMSCs oder Placebo zuzuweisen. Die Randomisierung gilt nur für berechtigte Probanden. Wenn ein Studienteilnehmer die Ein- und Ausschlusskriterien während des Screening-Prozesses nicht erfüllt, wird er/sie als Screen Failure (SF) betrachtet und eine Randomisierung ist nicht erforderlich.
  • Besuch 2 – Infusion 1 (Baseline): Dieser Besuch wird als Ausgangspunkt für den Vergleich der Teilnehmerdaten verwendet. Während dieses Besuchs erhalten geeignete Studienteilnehmer ihre erste Prüfpräparatverabreichung oder Placebo mit Überwachung der Vitalfunktionen für insgesamt 2 Stunden nach der Arzneimittelexposition. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Visite 3 – Infusion 2: Etwa 4 Wochen nach der ersten Verabreichung des Prüfpräparats sollte diese Visite abgeschlossen sein. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Visite 4 – Infusion 3: Etwa 8 Wochen nach der ersten Verabreichung des Prüfpräparats sollte diese Visite abgeschlossen sein. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Visite 5 – Infusion 4: Etwa 12 Wochen nach der ersten Verabreichung des Prüfpräparats sollte diese Visite abgeschlossen sein. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Visite 6 – Infusion 5: Etwa 16 Wochen nach der ersten Verabreichung des Prüfpräparats sollte diese Visite abgeschlossen sein. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Visite 7 – Infusion 6: Etwa 20 Wochen nach der ersten Verabreichung des Prüfpräparats sollte diese Visite abgeschlossen sein. Andere Studienauswertungen werden im Rahmen dieses Besuchs durchgeführt.
  • Telefonanruf – Nachsorge zur Sicherheit: Ungefähr 24 Wochen nach der anfänglichen Verabreichung des Prüfpräparats führen aktive Studienteilnehmer ein Nachsorge-Telefonat durch.
  • Telefonanruf – Nachsorge zur Sicherheit: Ungefähr 32 Wochen nach der anfänglichen Verabreichung des Prüfpräparats führen aktive Studienteilnehmer eine Nachuntersuchung per Telefonanruf durch.
  • Visite 8 – Ende der Studie, während dieser letzten Visite (ungefähr 52 Wochen nach Woche 0) wird eine vollständige Gruppe von Studienbewertungen durchgeführt, um die Sicherheit und Wirksamkeit von allogenen HB-adMSCs oder Placebo-Verabreichungen zu bewerten.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • Sugar Land, Texas, Vereinigte Staaten, 77478
        • Hope Biosciences Stem Cell Research Foundation

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Ein Studienteilnehmer kann nur dann in diese Studie aufgenommen werden, wenn alle folgenden Kriterien zutreffen:

    1. Männliche und weibliche Teilnehmer im Alter von 45 - 80 Jahren.
    2. Beim Screening-Besuch müssen die Studienteilnehmer einen MDS-UPDRS Teil II-Score zwischen 7 und 28 haben.
    3. Studienteilnehmer müssen während des Screening-Besuchs einen MDS-UPDRS Part III-Score zwischen 20 und 57 haben.
    4. Die Carbidopa/Levodopa-Gesamtdosis muss für die Studienteilnehmer weniger als 1200 mg pro Tag betragen.
    5. Die gesamte Levodopa-Äquivalentdosis für die Studienteilnehmer muss weniger als 1400 mg pro Tag betragen.
    6. Der Studienteilnehmer muss mindestens 2 Jahre vor Studienteilnahme mit früher und/oder mittelschwerer Parkinson-Krankheit diagnostiziert worden sein.
    7. Die Studienteilnehmer sollten in der Lage sein, die schriftliche Einwilligung zu lesen, zu verstehen und zu erteilen.
    8. Freiwillige unterzeichnete Einverständniserklärung, die vor der Durchführung von Verfahren im Zusammenhang mit klinischen Studien eingeholt wurde.
    9. Weibliche Studienteilnehmerinnen sollten während der Studienteilnahme und für 6 Monate nach der letzten Verabreichung des Prüfpräparats nicht schwanger sein oder eine Schwangerschaft planen.
    10. Männliche Teilnehmer, deren Sexualpartner schwanger werden können, sollten während der Studienteilnahme und für 6 Monate nach der letzten Verabreichung des untersuchten Produkts eine Verhütungsmethode anwenden.
    11. Der Studienteilnehmer ist in der Lage und willens, die Anforderungen dieser klinischen Studie zu erfüllen.

Ausschlusskriterien:

  • Ein Studienteilnehmer kann nicht in diese klinische Studie aufgenommen werden, wenn eines der folgenden Kriterien zutrifft:

    1. Schwangerschaft, Stillzeit. Frauen im gebärfähigen Alter, die nicht schwanger sind, aber keine wirksamen Verhütungsmaßnahmen anwenden.
    2. Studienteilnehmer mit fortgeschrittener Parkinson-Krankheit, beschrieben als schwere Behinderung, an den Rollstuhl gebunden oder bettlägerig.
    3. Der Studienteilnehmer hat eine aktive Malignität, einschließlich Anzeichen eines kutanen Basalkarzinoms, Plattenepithelkarzinoms oder Melanoms.
    4. Der Studienteilnehmer hat eine bekannte Alkoholabhängigkeit oder -abhängigkeit oder hat einen aktuellen Drogenkonsum oder -missbrauch.

    5. Der Studienteilnehmer hat 1 oder mehrere signifikante Begleiterkrankungen (bestätigt durch Krankenakten), einschließlich der folgenden:

      • Schlecht eingestellter Diabetes mellitus (PCDM), definiert als mangelhafte Standardbehandlung in der Anamnese und/oder präprandialer Blutzucker > 130 mg/dl während des Screeningbesuchs oder postprandialer Blutzucker > 200 mg/dl.
      • Anamnese der Diagnose einer chronischen Nierenerkrankung (CKD) und/oder Screening-Ergebnisse von eGFR < 59 ml/min/1,73 m2.
      • Vorhandensein einer Herzinsuffizienz der Klasse III/IV der New York Heart Association (NYHA) während des Screening-Besuchs.
      • Jegliche Anamnese eines Myokardinfarkts in einer der verschiedenen Arten, wie z. B. Myokardinfarkt mit ST-Hebung (STEMI) oder Myokardinfarkt ohne ST-Hebung (NSTEMI), Koronarspasmus oder instabile Angina pectoris.
      • Krankengeschichte von unkontrolliertem Bluthochdruck, definiert als mangelhafte Standardbehandlung und/oder Blutdruck > 180/120 mm/Hg während des Screening-Besuchs.
      • Anamnestisch vererbte Thrombophilie, kürzliche größere allgemeine Operation (innerhalb von 12 Monaten vor dem Screening), Lähmung der unteren Extremitäten aufgrund einer Rückenmarksverletzung, Becken-, Hüft- oder Femurfraktur, Krebs der Lunge, des Gehirns, des Lymphsystems, des gynäkologischen Systems ( Eierstock oder Gebärmutter) oder Magen-Darm-Trakt (wie Bauchspeicheldrüse oder Magen).
      • Geschichte der Gehirnchirurgie bei der Parkinson-Krankheit.
    6. Der Studienteilnehmer hat innerhalb von 6 Monaten vor der ersten Dosis des Prüfpräparats eine andere Stammzellbehandlung als von Hope Biosciences hergestellte Stammzellen erhalten.
    7. Erhalt einer Prüftherapie oder einer zugelassenen Therapie für Prüfzwecke innerhalb von 1 Jahr vor der ersten Dosis des Prüfpräparats mit Ausnahme von COVID-19-Impfstoffen.

    8. Der Studienteilnehmer hat während des Screenings eine Laboranomalie, einschließlich der folgenden:

      • Leukozytenzahl < 3000/mm3
      • Thrombozytenzahl < 80.000 mm3
      • Absolute Neutrophilenzahl < 1500/mm3
      • Alaninaminotransferase (ALT) oder Aspartataminotransferase (AST) 10 Obergrenze des Normalwerts (ULN) x 1,5
    9. Der Studienteilnehmer hat eine andere Laboranomalie oder einen medizinischen Zustand, der nach Ansicht des Prüfarztes ein Sicherheitsrisiko darstellt oder den Probanden daran hindert, die Studie abzuschließen.
    10. Es ist unwahrscheinlich, dass der Studienteilnehmer die Studie abschließt oder sich an die Studienverfahren hält.
    11. Studienteilnehmer mit bekannter gleichzeitiger akuter oder chronischer Virusinfektion mit Hepatis B oder C oder dem humanen Immundefizienzvirus (HIV).
    12. Der Studienteilnehmer hat eine zuvor diagnostizierte psychiatrische Erkrankung, die nach Ansicht des Prüfarztes die Selbsteinschätzung beeinflussen kann.
    13. Studienteilnehmer mit einer systemischen Infektion, die eine Behandlung mit Antibiotika, Virostatika oder Antimykotika innerhalb von 30 Tagen vor der ersten Dosis des Prüfprodukts erfordert.
    14. Männliche Studienteilnehmer, die planen, während der Studie oder innerhalb von 6 Monaten nach der letzten Dosis Samen zu spenden. Patientinnen, die planen, während der Studie oder innerhalb von 6 Monaten nach der letzten Dosis Eizellen zu spenden oder sich einer In-vitro-Fertilisationsbehandlung zu unterziehen.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Allogene HB-adMSCs.

Biologisch/Impfstoff: Allogene HB-adMSCs

Allogene HB-adMSCs werden Studienteilnehmern, die sich dafür qualifizieren, intravenös verabreicht.

Andere Namen: Allogeneic Hope Biosciences aus Fett gewonnene mesenchymale Stammzellen.
Biologisch: Biologisch/Impfstoff: Allogene HB-adMSCs
HB-adMSCs werden qualifizierten Studienteilnehmern intravenös verabreicht.
Andere Namen:
  • Allogeneic Hope Biosciences aus Fett gewonnene mesenchymale Stammzellen.
Sonstiges: Placebo
Sterile Kochsalzlösung 0,9 %
Andere Namen:
  • Placebo wird Studienteilnehmern, die sich dafür qualifizieren, intravenös verabreicht.
Placebo-Komparator: Placebo

Placebo wird Studienteilnehmern, die sich dafür qualifizieren, intravenös verabreicht.

Andere Namen: Sterile Kochsalzlösung 0,9 %
Biologisch: Biologisch/Impfstoff: Allogene HB-adMSCs
HB-adMSCs werden qualifizierten Studienteilnehmern intravenös verabreicht.
Andere Namen:
  • Allogeneic Hope Biosciences aus Fett gewonnene mesenchymale Stammzellen.
Sonstiges: Placebo
Sterile Kochsalzlösung 0,9 %
Andere Namen:
  • Placebo wird Studienteilnehmern, die sich dafür qualifizieren, intravenös verabreicht.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in MDS-UPDRS Part III Total Score
Zeitfenster: 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 (Statistical Analysis - RMA Model)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in MDS-UPDRS Part I Total Score
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52

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
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
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
Zeitfenster: Baseline to Weeks 52
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.
Baseline to Weeks 52
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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]
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 - %)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Cardiovascular
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - HEENT
Zeitfenster: 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
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Musculoskeletal
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Neurological
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Respiratory
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52
Physical Examination - by Treatment Week - Skin
Zeitfenster: Baseline to Weeks 52
Physical examination - by treatment week - Summary - Safety analysis set
Baseline to Weeks 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hope Biosciences Research Foundation

Mitarbeiter

Hope Biosciences

Ermittler

  • Hauptermittler: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Juli 2021

Primärer Abschluss (Tatsächlich)

3. Oktober 2025

Studienabschluss (Tatsächlich)

3. Oktober 2025

Studienanmeldedaten

Zuerst eingereicht

16. Juli 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. August 2021

Zuerst gepostet (Tatsächlich)

6. August 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HBPD04

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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