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NCT03444038 · ClinicalTrials.gov registry record · Phase 2
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT03444038: Completed Phase 2 study, sponsored by Neurocrine Biosciences.
NCT03444038 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03444038, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
Primary Outcome
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold.
Interventions
- DRUG Valbenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2019-07-12 |
| Phase | Phase 2 |
What the finished NCT03444038 record still lists
NCT03444038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which Valbenazine is the first listed.
NCT03444038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03444038 about?
NCT03444038 is a clinical study titled "Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome". This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
What is the current status of trial NCT03444038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2018-02-08. Estimated completion is 2019-07-12.
What interventions are being tested in trial NCT03444038?
The interventions under investigation include: Valbenazine (DRUG).
Who is sponsoring clinical trial NCT03444038?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03444038's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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