- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21205
- Kennedy Krieger Institute
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: George Capone, MD, Kennedy Krieger Institute/Johns Hopkins
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Manifestazioni neurocomportamentali
- Patologia
- Anomalie congenite
- Malattie genetiche, congenite
- Disabilità intellettuale
- Anomalie multiple
- Disturbi cromosomici
- Sindrome
- Sindrome di Down
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti colinergici
- Inibitori enzimatici
- Agenti neuroprotettivi
- Agenti protettivi
- Inibitori della colinesterasi
- Rivastigmina
Altri numeri di identificazione dello studio
- Pro00013682
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sindrome di Down
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Rachel G. Greenberg, MD, MB, MHSEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriNon ancora reclutamentoIperattività nei bambini con sindrome di Down | Impulsività nei bambini con sindrome di DownStati Uniti
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Hoffmann-La RocheCompletatoVolontariato sano, sindrome di DownRegno Unito
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Cairo UniversityCompletato
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Institute of Child HealthCompletato
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Parc de Salut MarCompletato
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Vanderbilt University Medical CenterNational Institute on Deafness and Other Communication Disorders (NIDCD)ReclutamentoIntervento sull'intelligibilità del parlato nella sindrome di DownStati Uniti
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Children's Oncology GroupNational Cancer Institute (NCI)CompletatoProliferazioni mieloidi associate alla sindrome di DownStati Uniti, Canada, Australia, Porto Rico
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Eastern Mediterranean UniversityCompletatoSindrome di Down, Trisomia 21Cipro
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Institut Jerome LejeuneFondation Jérôme LejeuneCompletatoSindrome di Down con e senza anomalie autoimmuniFrancia
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Boston Children's HospitalCompletato