At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
Valbenazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Valbenazine and Placebo oral capsule for Tourette Syndrome. Completed, enrolled 127 participants across 35 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedOct 2017
Primary CompletionNov 2018
Study CompletionNov 2018
TodayJul 2026
First PostedOct 30, 2017
Enrollment StartOct 5, 2017
Primary CompletionNov 1, 2018
Study CompletionNov 16, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.7 years ago
Interventions
Valbenazinedrug
vesicular monoamine transporter 2 (VMAT2) inhibitor
Placebo oral capsuledrug
non-active dosage form