drugset / Trial / NCT03325010

Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

NCT03325010

Phase 2 Completed 127 enrolled Neurocrine Biosciences
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2017-10-05
Primary completion
2018-11-01
Completion
2018-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Valbenazine Small molecule 20 mg
Subject Valbenazine Small molecule 40 mg
Subject Valbenazine Small molecule 60 mg
Subject Valbenazine Small molecule 80 mg

Indications