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NCT03530293 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT03530293: Clinical Trial Phase 2 study, sponsored by Neurocrine Biosciences.
NCT03530293 is a Phase 2 study that was terminated before completion, run by Neurocrine Biosciences. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03530293, a Phase 2 study, was terminated before completion, sponsored by Neurocrine Biosciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
Primary Outcome
Loss of treatment response during the withdrawal period was defined as: 2 consecutive visits with 1) an increase in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) of greater than 35% or 7 points from the randomized withdrawal period baseline and 2) an increase in CGI-Tics-Severity score of ≥2 points from the randomized withdrawal period baseline; or discontinuation due to lack of efficacy or a treatment-emergent adverse event (TEAE) of worsening of tics. Median (lower and upper
Interventions
- DRUG Placebo oral capsule
- DRUG Valbenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 2 |
Why NCT03530293 stopped before completion
NCT03530293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03530293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03530293 about?
NCT03530293 is a clinical study titled "Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome". This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
What is the current status of trial NCT03530293?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2018-04-17. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03530293?
The interventions under investigation include: Placebo oral capsule (DRUG), Valbenazine (DRUG).
Who is sponsoring clinical trial NCT03530293?
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 NCT03530293's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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