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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 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.

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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.

Conditions Studied

Autism Autistic Disorder

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

FieldValue
Enrollment Target 96 participants
Start Date 2007-12
Est. Completion 2010-03
Phase Phase 4

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

102 total trials

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What the Registry Record Tells You About NCT00576732

The ClinicalTrials.gov registry entry for NCT00576732 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 104 other Autism trials with a reported enrollment target (47% lower). The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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

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.