Phase 3 Valbenazine for Chorea in Huntington Disease Completes Enrollment

The phase 3 KINECT-HD clinical study (NCT04102579)  of valbenazine (Ingrezza; Neurocrine Biosciences, San Diego, CA) for treatment of chorea in Huntington disease (HD) has completed enrollment. The clinical trial is comparing valbenazinetreatment with placebo and will also evaluate the ability of wearable movement sensors to detect changes in physical activity.

Participants who complete the KINECT-HD trial can also enroll in the KINECT-HD2 extension study to evaluate the long-term safety and tolerability of valbenazine to manage hyperkinetic movement.
 
"This milestone reflects the progress that we have made in advancing valbenazine as a potential treatment for people living with chorea in Huntington disease and we look forward to sharing top-line results later this year," said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences. "I'd like to thank our partners at the Huntington Study Group, the Clinical Trials Coordination Center at the University of Rochester, New York, the KINECT-HD investigative staff, and especially the patients and families for their commitment and perseverance in completing enrollment in the face of all the challenges posed by the pandemic."

Valbenazine is a vesicle monoamine transporter-2 (VMAT-2) inhibitor that reduces the amount of dopamine available at the synapse. Valbenazine was developed to fulfill the unmet medical needs of individuals with hyperkinetic movement disorders and is approved by the Food and Drug Administration (FDA) for tardive dyskinesia treatment. 

The main adverse event of valbenazine when compared with placebo is sedation.