- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01084135
Rivastigmine Study in Adolescents With Down Syndrome (DS-Riv)
A 20-Week Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Rivastigmine in Children (Ages 10-18) With Down Syndrome
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This 24 week, double-blind, placebo controlled trial will be completed at the Clinical Research Unit of Duke University Medical Center and at the Kennedy Krieger Institute (KKI). Sixteen evaluable subjects will be enrolled at Duke and 24 evaluable subjects will be enrolled at KKI. The study consists of four visits, a screening visit (-4 weeks), a baseline visit (week 0); a safety visit at week 10, and a final/termination visit at week 20.
The specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate treatment; b) build upon our open-label treatment results of overall function and language improvement in adolescents with Down syndrome (DS) in a double-blind, placebo-controlled clinical trial; and c) investigate other specific cognitive domains that may selectively respond to rivastigmine tartrate treatment.
The original IRB-approved protocol included the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) . The protocol was amended to replace the Parent/Caregiver Rating Form of the Vineland Adaptive Behavior Scales- Second Edition (VABS-II) with the Vineland Adaptive Behavior Scales, Second Edition, Survey Interview Form. The protocol was also amended to extend the trial from 12 weeks to 20 weeks. Due to the changes in the amended protocol the subject enrolled prior to the IRB amendment will not be included in the data analysis section.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Kennedy Krieger Institute
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Correct VERBAL responses for 7/9 of the Expressive One Word Picture Vocabulary Test items.
- Subject able to put at least 2-3 words together in conversational speech.
- Subject's speech is understandable to the examiner for the majority of the time.
- Subjects are in good health and medically stable
Exclusion Criteria:
- Subject uses sign language as a primary means of communication
- Subject has a medical history that contraindicate the use of rivastigmine (For example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).
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 |
---|---|
Eksperimentel: Rivastigmine- Liquid form
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid.
This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks.
At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks.
If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid.
If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
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At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid.
This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks.
At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks.
Subjects receiving placebo will maintain the same schedule.
If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid.
If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
Andre navne:
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Placebo komparator: Liquid placebo
Subjects receiving placebo will maintain matched titration volume increase as treatment arm.
The placebo will be matched to liquid rivastigmine in consistency and taste.
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Subjects receiving placebo will maintain matched titration volume increase as treatment arm.
The placebo will be matched to liquid rivastigmine in consistency and taste.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)
Tidsramme: Baseline & Study termination (Week 20)
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The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults.
It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains.
ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160).
Higher scores suggest a higher level of adaptive functioning.
In this study, the change between each subject's ABC at Baseline and the Final Visit was computed.
A rise in standard scores from Baseline to the Final Visit indicates improvement.
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Baseline & Study termination (Week 20)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)
Tidsramme: Baseline and Final (Week 20) visit
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The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting.
It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales.
Raw scores range from 63 to 189.
Higher scores suggest that an individual's executive function skills are more problematic.
In this study, the change between each subject's raw score at Baseline and the Final Visit was computed for the Global Executive Composite.
A decline in raw scores from Baseline to the Final Visit indicates improvement.
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Baseline and Final (Week 20) visit
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: George Capone, MD, Kennedy Krieger Institute/Johns Hopkins
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Sygdom
- Medfødte abnormiteter
- Genetiske sygdomme, medfødte
- Intellektuel handicap
- Abnormiteter, multiple
- Kromosomlidelser
- Syndrom
- Downs syndrom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhæmmere
- Neuroprotektive midler
- Beskyttelsesagenter
- Cholinesterasehæmmere
- Rivastigmin
Andre undersøgelses-id-numre
- Pro00013682
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Downs syndrom
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Zealand University HospitalRigshospitalet, Denmark; Herlev HospitalUkendtNeoadjuverende terapi | Lokalt avanceret endetarmskræft | Elektrokemoterapi | Down StagingDanmark
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University of Colorado, DenverRekrutteringKlinefelters syndrom | Trisomi X | XYY syndrom | XXXY og XXXXY syndrom | Xxyy syndrom | Xyyy syndrom | Xxxx syndrom | Xxxxx syndrom | Xxxyy syndrom | Xxyyy syndrom | Xyyyy syndrom | Mand med sexkromosommosaicismeForenede Stater
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Riphah International UniversityAfsluttet
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Riphah International UniversityAfsluttet
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Shaare Zedek Medical CenterUkendtPræmenstruelt syndrom - PMS
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Esra ÖZERKTO Karatay UniversityRekrutteringEffekten af aromaterapiapplikation med bergamot og grapefrugt æteriske olier på PMS (Aromatherapy)Præmenstruelt syndrom - PMSKalkun
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Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.AfsluttetTidligere behandlet myelodysplastisk syndrom | Myelodysplastisk syndrom | Terapi-relateret myelodysplastisk syndrom | Sekundært myelodysplastisk syndrom | Refraktært højrisiko myelodysplastisk syndromForenede Stater
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Hrain Biotechnology Co., Ltd.Shanghai Changzheng HospitalAktiv, ikke rekrutterendePOMES syndrom | Tilbagefaldende og refraktær POMES-syndromKina
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Riphah International UniversityRekrutteringNedre kors syndromPakistan
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Foundation University IslamabadRekruttering
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