Clinical Trials

Tardive Dyskinesia

KINECT 4 is an ongoing, randomized,  one year Phase 3 safety study of INGREZZA (valbenazine) capsules 40mg and 80mg once daily in patients with Moderate-Severe Tardive Dyskinesia. For more information on the study, please click here.

Tourette Syndrome

T-Forward Study

Neurocrine completed a Phase 2 study of valbenazine in adults with Tourette Syndrome. The T-Forward study was 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 consistent 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.

For more information on the T-Forward study visit: www.tforcegreen.com.