Trials / Completed
CompletedNCT03325010
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Optimization Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-optimization study to evaluate the efficacy, safety, and tolerability of NBI-98854 titrated to the subject's optimal dose administered once daily (qd) for a total of 12 weeks of treatment in pediatric subjects with TS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Valbenazine | vesicular monoamine transporter 2 (VMAT2) inhibitor |
| DRUG | Placebo oral capsule | non-active dosage form |
Timeline
- Start date
- 2017-10-05
- Primary completion
- 2018-11-01
- Completion
- 2018-11-16
- First posted
- 2017-10-30
- Last updated
- 2021-06-28
- Results posted
- 2021-06-28
Locations
35 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03325010. Inclusion in this directory is not an endorsement.