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NewsHSG UPDATES: Current Clinical Trials – KINECT-HD2 and PROOF-HD


July 2022

KINECT-HD2 is being conducted by Neurocrine Biosciences, Inc. (“Sponsor”) in partnership with the Huntington Study Group (HSG). KINECT-HD2 is an open-label, multi-center study with sites across the US and Canada and aims to investigate the long-term safety and tolerability, as well as the maintenance of effect of valbenazine for the treatment of chorea associated with HD. Participation in this study will last up to approximately 162 weeks, including up to 4 weeks (28 days) of screening, up to 156 weeks of treatment (about 39 months or approximately 3 years), and a final study visit 2 weeks (14 days) after stopping study drug. The entire study consists of up to approximately 22 study visits. The enrollment goal is to reach approximately 150 participants. KINECT-HD2 was recently amended to include participants on stable background treatment of antipsychotic medication, and is currently open to enrollment.

We are incredibly grateful to all the study participants, study sites, referring sites, Sponsor and study teams for their continued dedication to the study.

If you know of any potential participants, please contact Jody Goldstein by phone (760-845-2105) or email (jody.goldstein@hsglimited.org).

For further information about Neurocrine Biosciences, Inc. and Valbenazine click on links below.

May 12, 2022
Neurocrine Biosciences Receives Orphan Drug Designation for Valbenazine as a Treatment for Chorea Associated with Huntington Disease

April 1, 2022 Press release (KINECT-HD)
Neurocrine Biosciences Presents Phase 3 Data for KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease at AAN 2022

PROOF-HD is a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington), is sponsored by Prilenia Therapeutics and led by the Huntington Study Group in collaboration with TFS, Clinical Trials Coordination Center (U Rochester), and several partner providers. The study is being conducted at 59 sites in North American and Europe, and enrollment was completed in October, 2021. Participant retention has been excellent with approximately 95% of enrolled participants remaining in the study. All active participants have reached the halfway point in the main (double-blind) portion of the study. A number of participants have completed the main study and have rolled over into the Open Label Extension (OLE). The next major milestones include the main study database lock planned for Q1 2023.

The global study team is excited to meet in person at upcoming meetings – the PROOF-HD European and North American Investigators and Coordinators will be meeting at the upcoming EHDN 2022 and HSG 2022 meetings in September and November, respectively.

On behalf of Prilenia and the study team, we are grateful for the collaborative effort of the PROOF-HD study sites, and most importantly, the dedication and commitment of all study participants and their families.