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NCT01171937 · ClinicalTrials.gov registry record · Phase 2
Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
A Phase 2 study of Autism, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01171937: Completed Phase 2 study of Autism, sponsored by University of California, Los Angeles.
NCT01171937 is a Phase 2 study of Autism that has completed, run by University of California, Los Angeles. The registered enrollment target is 41 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01171937, a Phase 2 study of Autism, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study attempts to deepen our understanding of repetitive behaviors in autism spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits associated with risperidone treatment using functional MRI. This study is a substudy of a larger center grant (IRB#07-03-066). Other studies also under this center grant, include: IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another sub-study, should they meet criteria. The proposed study will address this aim by mounting a controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment, children will enter a three-part study. Phase 1 will be an 8-week, double-blind, placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week open-label maintenance phase for responders to risperidone or placebo. Non-responders to placebo will be invited to enroll in the eight-week open-label study. 48 of the participants will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to 4.0mg.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Risperidone
Study Locations (1)
California
- UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT01171937 record still lists
NCT01171937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01171937 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01171937 about?
NCT01171937 is a clinical study titled "Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior". The proposed study attempts to deepen our understanding of repetitive behaviors in autism spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits associated with risperidone treatment using functional MRI. This study is a substudy of a larger center grant (IRB#07-0...
What is the current status of trial NCT01171937?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2008-09. Estimated completion is 2016-12.
What conditions does trial NCT01171937 study?
This clinical trial studies the following conditions: Autism.
What interventions are being tested in trial NCT01171937?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG).
Who is sponsoring clinical trial NCT01171937?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01171937 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
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 NCT01171937's enrollment target sits among peer trials
41 66th of 104 higher than 39 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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