A Clinical Study for Huntington Disease Chorea

PURPOSE OF THE KINECT-HD STUDY

Valbenazine (valbenazine tosylate, NBI-98854) is a selective, orally active VMAT2 inhibitor developed by Neurocrine Biosciences, Inc. that is being investigated for the treatment of chorea associated with Huntington disease (HD). The study drug, valbenazine, has been approved by the United States Food and Drug Administration (FDA) in April 2017 for the treatment of adults with tardive dyskinesia (TD), under the trade name INGREZZA®.

KINECT-HD is a Phase 3, randomized, double-blind, placebo-controlled study. The objectives of KINECT-HD are to:

Evaluate the efficacy of valbenazine to reduce chorea associated with HD
Evaluate the safety and tolerability of valbenazine in subjects with HD
Evaluate the ability of wearable movement sensors to detect changes in physical activity (optional activity)

WHO MAY QUALIFY?

Eligible participants must meet the following criteria, in addition to other criteria:

Male or female, ages of 18 to 75 years
Diagnosis of motor manifest HD
Have sufficient chorea symptoms to meet study protocol criteria
Willing and able to comply with the study instructions

There are additional eligibility requirements that the Clinical Investigator can explain to you.

STUDY SCHEDULE

Participation in the KINECT-HD study lasts approximately eighteen (18) weeks and includes a screening period, a study drug period, and a follow-up period. Participants will need to attend nine (9) study visits throughout the study.

Screening

After you consent to participate in the study, you will need to attend a screening visit, where your Clinical Investigator will perform tests and procedures to confirm your eligibility to take part in the study. The screening portion of the study will last up to four (4) weeks.

Study Drug Dosing

If you qualify based on the study eligibility criteria, you will be in this part of the study for twelve (12) weeks. During this twelve (12)-week period, eligible subjects will by randomized 1:1 to receive either the study drug or placebo. The placebo looks like the study drug (valbenazine), but it does not contain any active medicine. Neither you nor the Clinical Investigator will know whether you are taking the study drug or placebo.

During this part of the study, you will first enter the dose adjustment period for eight (8) weeks. During the dose-adjustment period, the Clinical Investigator will increase your dose to the next dose level if, in the Clinical Investigator’s opinion, you have tolerated the study drug at the current dose. Doses will be adjusted in a blinded manner. If you are receiving the placebo, you will also undergo the dose-adjustment process but will continue to receive the placebo.

Following the 8-week dose adjustment period, you will enter a dose maintenance period for four (4) weeks. During the maintenance period, your dose of the study drug or placebo will be maintained. However, if you are not able to tolerate the study drug, Clinical Investigator may adjust the dose to be lower.

Follow-Up

A final checkup will be done two (2) weeks after you stop taking the study drug or placebo, or when you leave the study.

HOW TO PARTICIPATE IN THIS CLINICAL TRIAL

KINECT-HD is being conducted by the Huntington Study Group (HSG), a leader in HD clinical trials for over 25 years. KINECT-HD will take place in approximately 46 study centers in the United States and Canada.

View active study locations.

If you are interested in participating in KINECT-HD, please contact the HSG to find a site nearest to you. Study center personnel will determine your eligibility to participate in the KINECT-HD study.

Call Toll-Free (North America): 800-487-7671
Email: info@hsglimited.org