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NCT01727713 · ClinicalTrials.gov registry record · Phase 3

Safety and Tolerability of Once-daily 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
110
Enrollment target

NCT01727713: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT01727713 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01727713, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 3
Development phase
110 participants
Enrollment target

Study Summary

The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Primary Outcome

An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse ev

Interventions

  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2013-01
Est. Completion 2014-09
Phase Phase 3

What the finished NCT01727713 record still lists

NCT01727713 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.

NCT01727713 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01727713 about?

NCT01727713 is a clinical study titled "Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder". The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

What is the current status of trial NCT01727713?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2013-01. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01727713?

The interventions under investigation include: Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT01727713?

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

How this trial's enrollment target compares

Where NCT01727713's enrollment target sits among peer trials

110 1657th of 2000 higher than 337 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01727713, the US trial registry maintained by the National Library of Medicine. NCT01727713 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.