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NCT03661983 · ClinicalTrials.gov registry record · Phase 4
Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder
A Phase 4 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT03661983: Clinical Trial Phase 4 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03661983 is a Phase 4 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03661983, a Phase 4 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
Primary Outcome
Relapse was defined as a loss of ≥ 50% of the improvement experienced during the open-label stabilization phase (i.e., improvement at the last assessment of Yale Global Tic Severity Scale (YGTSS) before randomization) on the Yale Global Tic Severity Scale Total Tic Score (YGTSS TTS). YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms.
Interventions
- DRUG Placebo
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-10-13 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 4 |
Why NCT03661983 stopped before completion
NCT03661983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03661983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03661983 about?
NCT03661983 is a clinical study titled "Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder". To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).
What is the current status of trial NCT03661983?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2018-10-13. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03661983?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT03661983?
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 NCT03661983's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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