Trials / Terminated
TerminatedNCT03530293
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Valbenazine | vesicular monoamine transporter 2 (VMAT2) inhibitor |
| DRUG | Placebo oral capsule | non-active dosage form |
Timeline
- Start date
- 2018-04-17
- Primary completion
- 2019-07-16
- Completion
- 2019-07-16
- First posted
- 2018-05-21
- Last updated
- 2022-05-17
- Results posted
- 2022-05-17
Locations
49 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03530293. Inclusion in this directory is not an endorsement.