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NCT00576732 · ClinicalTrials.gov registry record · Phase 4
A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder
A Phase 4 study of Autism and Autistic Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 4
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT00576732: Completed Phase 4 study of Autism and Autistic Disorder, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00576732 is a Phase 4 study of Autism and Autistic Disorder that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 96 participants, below the 182-participant average among 104 other Autism trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576732, a Phase 4 study of Autism and Autistic Disorder, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who have autism, and to evaluate the safety and tolerability of the drug for additional 26 weeks after the initial 6-week study period.
Primary Outcome
Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Risperidone high dose
- DRUG Risperidone low dose
Study Locations (20)
New York
- - Manhasset
- - New York
- - Staten Island
- - The Bronx
California
- - Sacramento
- - Santa Ana
Florida
- - Boca Raton
- - Miami
Illinois
- - Hoffman Estates
- - Naperville
Virginia
- - Fairfax
- - Portsmouth
Alabama
- - Dothan
Arizona
- - Phoenix
Georgia
- - Smyrna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
What the finished NCT00576732 record still lists
NCT00576732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 182-participant average among 104 other Autism trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Autism appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00576732 names 20 study sites across 13 states, led by New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00576732 about?
NCT00576732 is a clinical study titled "A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder". The purpose of this study is to evaluate the effectiveness (change in level of irritability and related behaviors) and safety and tolerability of the administration of 2 different fixed dose levels of risperidone (an atypical antipsychotic drug) compared with placebo in children or adolescents who h...
What is the current status of trial NCT00576732?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2007-12. Estimated completion is 2010-03.
What conditions does trial NCT00576732 study?
This clinical trial studies the following conditions: Autism, Autistic Disorder.
What interventions are being tested in trial NCT00576732?
The interventions under investigation include: Placebo (DRUG), Risperidone high dose (DRUG), Risperidone low dose (DRUG).
Who is sponsoring clinical trial NCT00576732?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00576732 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00576732's enrollment target sits among peer trials
96 42nd of 104 higher than 63 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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