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NCT01416441 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability 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
- 170
- Enrollment target
NCT01416441: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01416441 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 170 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416441, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
Study Summary
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration.
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2011-10-19 |
| Est. Completion | 2014-03-13 |
| Phase | Phase 3 |
What the finished NCT01416441 record still lists
NCT01416441 is an interventional study that assigns participants to a tested intervention. The registered 170 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 (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT01416441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416441 about?
NCT01416441 is a clinical study titled "Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder". The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.
What is the current status of trial NCT01416441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2011-10-19. Estimated completion is 2014-03-13.
What interventions are being tested in trial NCT01416441?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT01416441?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416441's enrollment target sits among peer trials
170 1453rd of 2000 higher than 542 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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