What is it
KINECT-HD is a Phase 3, randomized, double-blind, placebo-controlled study
Objective
To evaluate the safety, tolerability and efficacy of valbenazine in reducing the chorea symptom associated with Huntington's disease.
Sponsor
The experimental drug
It is called valbenazine (valbenazine tosylate, NBI-98854). Tt is a selective and active VMAT2 inhibitor studied for the treatment of chorea associated with Huntington's disease. The drug is currently on the market for the treatment of tardive dyskinesia, under the trade name INGREZZA.
Drug Administration
The drug is administered orally, one tablet per day for 12 weeks
Study location an number of participants
46 HD Centres in US and Canada; 120 participants in total.
Duration
18 weeks, including a screening period, a drug versus placebo period, and a follow-up period. Participants will be required to participate in nine (9) visits during the study. A final check will be done two (2) weeks after stopping the drug or placebo, or at the end of the study.
Inclusion criteria
Age 18 - 75
Diagnosis of Huntington with manifest motor symptoms
Starting date
November 2019
Estimated ending date
Sptember 2021
Learn more on: clicaltrials.gov
