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NCT00211757 · ClinicalTrials.gov registry record · Phase 2
Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism
A Phase 2 study of Autism, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT00211757: Completed Phase 2 study of Autism, sponsored by Montefiore Medical Center.
NCT00211757 is a Phase 2 study of Autism that has completed, run by Montefiore Medical Center. The registered enrollment target is 27 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00211757, a Phase 2 study of Autism, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms.
Primary Outcome
The CGI-I is a 7-point improvement scale. Ratings of 1 or 2 (responders) indicate a substantial reduction in symptoms. A rating of 3 (minimally improved) on the CGI is defined as a slight symptomatic improvement that is not deemed clinically significant; patients with such an improvement were not considered responders. Two versions of this test were used, one focused on irritability (primary outcome measure) and a general version CGI-I-autism focused on all symptoms including core symptom domain
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Divalproex sodium
Study Locations (1)
New York
- Mount Sinai School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2002-09 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00211757 record still lists
NCT00211757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (85% 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.
NCT00211757 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00211757 about?
NCT00211757 is a clinical study titled "Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism". The study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational th...
What is the current status of trial NCT00211757?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2002-09. Estimated completion is 2008-07.
What conditions does trial NCT00211757 study?
This clinical trial studies the following conditions: Autism.
What interventions are being tested in trial NCT00211757?
The interventions under investigation include: Placebo (DRUG), Divalproex sodium (DRUG).
Who is sponsoring clinical trial NCT00211757?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00211757 being conducted?
This trial has 1 study location across New York. 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 NCT00211757's enrollment target sits among peer trials
27 78th of 104 higher than 27 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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