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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 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.

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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

Autism

Interventions

  • DRUG Placebo
  • DRUG Risperidone

Study Locations (1)

California

  • UCLA - Los Angeles

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2008-09
Est. Completion 2016-12
Phase Phase 2

Sponsor

University of California, Los Angeles

897 total trials

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What the Registry Record Tells You About NCT01171937

The ClinicalTrials.gov registry entry for NCT01171937 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 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 (78% lower). The listed sponsor is University of California, Los Angeles, which has 897 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.

NCT01171937 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.