Clinical Trials

INGREZZA™ (valbenazine) capsules: An investigational treatment for Tourette syndrome

STUDIES IN TOURETTE SYNDROME

T-Forward Study

Neurocrine completed a Phase 2 study of valbenazine in adults with Tourette syndrome. The T-Forward study a randomized, double-blind, placebo-controlled, multi-dose, parallel group study of 124 adults. Subjects received once-daily dosing of valbenazine during an eight-week treatment period assessing the safety, tolerability and efficacy of valbenazine in Tourette patients. The primary endpoint of this study was the change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

While the T-Forward study showed a significant improvement in overall symptoms of Tourette syndrome as evidenced by the Clinical Global Impression of Change (p=0.015), the pre-specified primary endpoint, the change from-baseline in the Yale Global Tic Severity Scale at Week 8 was not met (p=0.18).  Adverse events were dose dependent and consisted with earlier clinical studies.

T-Force GREEN Study

In early 2016, the company initiated a Phase 2 study of valbenazine in children and adolescents with Tourette syndrome. The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 children and adolescents between the ages of 6 and 17 years old. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in Tourette patients. The primary endpoint of this study is the change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 6.

T-Fusion Study

The T-Fusion study is an open-labeled extension study for subjects (pediatric and adult) who have completed the T-Forward study or the T-Force GREEN study and who elect to continue receiving INGREZZA for an additional 24 weeks of treatment.  Safety and efficacy assessments are conducted as outlined in the preceding studies.  This study commenced in July 2016 and the last subject is expected to complete treatment during 2017.

CP-TS-US-0001 9/16