CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
Valbenazinedrug
Likely dose
Valbenazine (specific dose not stated in available information)AI-extracted
Key inclusion· 6
  • ✓Completed prior NBI-98854 Phase 2 study (T-Force Green or T-Forward)
  • ✓Clinical diagnosis of Tourette Syndrome
  • ✓Age 12-64 years
  • ✓If on TS maintenance medications, must be at stable doses
Key exclusion· 8
  • ✕Active, clinically significant unstable medical condition within 1 month prior to screening
  • ✕Known history of long QT syndrome or cardiac arrhythmia
  • ✕Known history of neuroleptic malignant syndrome
  • ✕Cancer diagnosis within 3 years prior to screening (some exceptions allowed)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879578
NCT02879578Phase 2Completed
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Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome

Neurocrine Biosciences·interventional·Posted Aug 25, 2016·Updated Apr 29, 2021

In Brief

A Phase 2 clinical trial evaluating Valbenazine for Tourette Syndrome. Completed, enrolled 155 participants across 13 sites.

Detailed Summary

Phase 2, open-label, fixed-dose titration study to evaluate the safety and tolerability of NBI-98854 administered once daily for a total of 24 weeks in children, adolescents, and adults with Tourette Syndrome (TS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartJul 25, 2016
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.9 years ago

Interventions

Valbenazinedrug