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Aripiprazole in Children With Autism
NCT00208533Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2004
- Primary completion
- Nov 2011
- Countries
- 1
- Sponsor
- Drexel University
- Modality
- Small Molecules
- Drugs
- aripiprazole
- Conditions
- Autism Spectrum Disorder (ASD)
01
Overview
Phase 2, open-label, single-arm trial of aripiprazole in Autism Spectrum Disorder (ASD), sponsored by Drexel University. Primary endpoint: Clinical Global Impressions at 6 weeks. Started Feb 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Open Label Aripiprazole
Aripiprazole 5-30 mg/day
03
Who it enrols
Adolescents aged 12-18 with a diagnosis of autism. Excludes those with major medical problems, uncontrolled seizures, baseline QTc > 425 msec, concomitant psychotropic medication, or prior exposure to aripiprazole.
04
Endpoints
Primary
Clinical Global Impressions
Secondary
Children's Psychiatric Rating Scale
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