KINECT-HD2 Study of Oral Valbenazine for Chorea Enrolling
The Huntington Study Group is seeking 30 patients to join KINECT-HD2, an open-label study of oral valbenazine capsules for chorea, or jerky involuntary movements, in Huntington’s disease, a press release states.
KINECT-HD2 is an extension study of KINECT-HD (NCT04102579), a Phase 3 clinical trial that tested the safety and efficacy of valbenazine to ease chorea for 12 weeks (about three months), as compared with a placebo.
The goal of the new study is to evaluate how safe and well-tolerated valbenazine is and how well it works when taken once daily for up to 104 weeks (roughly two years).
It will enroll about 150 patients with Huntington’s, 120 of whom will roll over from KINECT-HD. Patients who terminated KINECT-HD early due to COVID-19 are also invited to enter the KINECT-HD2 study. They must contact their study site investigator or coordinator for more information.
New participants will go through a screening process to make sure they meet all inclusion criteria. In addition to other requirements, they must be 18 to 75 years old and manifest motor symptoms of the disease, including chorea.
KINECT-HD2 will take place at about 45 sites in the U.S. and Canada.
Chorea, a common motor symptom of Huntington’s, is characterized by rapid involuntary movements that are irregular and unpredictable. It is thought that chorea occurs when there is too much of the neurotransmitter dopamine — a chemical that plays a role in motor control — in the brain.
Neurocrine Biosciences’ valbenazine, also known as valbenazine tosylate or NBI-98854, is an inhibitor of vesicular monoamine transporter-2 (VMAT-2), a protein that controls the release of dopamine from nerve cells. It works by reducing the amount of dopamine available in the brain. As a result, it aims to lessen involuntary movements.
It is approved by the U.S. Food and Drug Administration (FDA) to treat adults with tardive dyskinesia, a movement disorder, under the brand name Ingrezza. Now it is being tested to treat chorea associated with Huntington’s.
As part of the KINECT-HD2 study, patients will first enter a dose adjustment period for eight weeks, during which they will take a daily dose of 20 mg to 80 mg of valbenazine up to the highest tolerated dose. Following the dose adjustment period, patients will enter a dose maintenance period until week 104, during which the chosen dose will be maintained. In total, they will attend 18 in-person study visits plus five phone or video calls.
The study will last up to 112 weeks and provide patients with valbenazine pending its possible regulatory approval by the FDA and commercial availability for the treatment of chorea associated with Huntington’s.
The most commonly reported side effects of valbenazine when compared with placebo are drowsiness and tiredness.