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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 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.

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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.

Conditions Studied

Autism

Interventions

  • DRUG Placebo
  • DRUG Divalproex sodium

Study Locations (1)

New York

  • Mount Sinai School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2002-09
Est. Completion 2008-07
Phase Phase 2

Sponsor

Montefiore Medical Center

345 total trials

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What the Registry Record Tells You About NCT00211757

The ClinicalTrials.gov registry entry for NCT00211757 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (85% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.