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.
The original Abnormal Involuntary Movement Scale, or AIMS, (Guy, 1976) had scores of 0-4 accompanied by the words “none, minimal, mild, moderate, severe” but no additional descriptors for each of the 7 body regions. Subsequently, many versions of the AIMS have been used with various descriptors added to help “anchor” the scoring but these have used words such as “unsightly” or other difficult to standardize or quantify for use of the scale in rigorous clinical trials. For our pivotal studies of INGREZZA™ (valbenazine) capsules, Neurocrine modified the AIMS to include the more precise capturing of frequency, amplitude and persistence of the involuntary movements allowing for greater inter-rater reliability and consistency of scoring.
The Abnormal Involuntary Movement Scale (AIMS) was the primary efficacy measure for the assessment of tardive dyskinesia severity. The AIMS is a 12-item scale; items 1 to 7 assess the severity of involuntary movements across body regions and these items were used in this study. Each of the 7 items was scored on a 0 to 4 scale, rated as: 0=no dyskinesia; 1=low amplitude, present during some but not most of the exam; 2=low amplitude and present during most of the exam (or moderate amplitude and present during some of the exam); 3=moderate amplitude and present during most of exam; or 4=maximal amplitude and present during most of exam. The AIMS dyskinesia total score (sum of items 1 to 7) could thus range from 0 to 28, with a decrease in score indicating improvement. The AIMS was scored by central raters who interpreted the videos blinded to subject identification, treatment assignment, and visit number.
A Phase IIIb rollover study has been initiated to allow open-label access to valbenazine (NBI-98854) for subjects who completed either Kinect 3 or Kinect 4. The study is designed to allow access to valbenazine until such time as it is commercially available.
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.
Policy on expanded access to investigational medicines
Individuals interested in participating in clinical trials for our products may visit the “Pipeline” section of our website for information on our ongoing clinical trials. At this time, Neurocrine does not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval. We will update this page as we grow and reassess our approach to expanded access programs. If you have any questions, please contact firstname.lastname@example.org.