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NCT01418339 · ClinicalTrials.gov registry record · Phase 3

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 3
Development phase
135
Enrollment target

NCT01418339 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 135 participants.

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The verdict

NCT01418339, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
135 participants
Enrollment target

Study Summary

The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Interventions

  • DRUG Placebo
  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2011-07-27
Est. Completion 2013-11-06
Phase Phase 3

What the Registry Record Tells You About NCT01418339

The ClinicalTrials.gov registry entry for NCT01418339 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01418339 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01418339 about?

NCT01418339 is a clinical study titled "Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder". The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

What is the current status of trial NCT01418339?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2011-07-27. Estimated completion is 2013-11-06.

What interventions are being tested in trial NCT01418339?

The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT01418339?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

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.