Frequently Asked Questions
What is Valbenazine
Valbenazine (valbenazine tosylate, NBI-98854) is a selective, orally active VMAT2 inhibitor developed by Neurocrine Biosciences, Inc. Valbenazine is being investigated for the treatment of chorea associated with HD. Valbenazine was 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®.
How many other clinical trials have there been with valbenazine?
Twenty-seven clinical studies with valbenazine have been completed to date: 16 Phase 1 studies in healthy subjects or special populations (for example, patients with impaired liver or kidney function); 7 Phase 2 or 3 studies in subjects with TD, and 4 Phase 1b or 2 studies in subjects with Tourette syndrome (TS; 1 in adults; 2 in children and adolescents; and 1 in children, adolescents, and adults).
What are the most common side effects of valbenazine?
Most commonly-reported side effects with valbenazine administration include drowsiness, tiredness and sedation (feeling calm, relaxed or sleepy).
Can valbenazine stop or slow the progression of HD?
Valbenazine is being evaluated as a symptomatic treatment of involuntary movement (chorea) associated with HD. Valbenazine is not an approved treatment or cure for HD.
Is there another name for valbenazine?
Valbenazine was 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®.
Is KINECT-HD currently enrolling participants?
Yes. KINECT-HD is actively enrolling approximately 120 patients.
Are there specific qualifications or exclusion criteria for this study?
Yes. There are several requirements that a participant must meet to be enrolled in KINECT-HD, including the following:
- Be male or female, ages of 18 to 75 years
- Have a diagnosis of motor manifest HD
- Have sufficient chorea symptoms to meet study protocol criteria
- Is willing and able to comply with the study instructions
There are additional eligibility requirements that the Clinical Investigator can explain to you.
How long will study participation last?
Participants enrolled in KINECT-HD will participate for a period of 18 weeks. The participation timeline includes a 4-week screening period, a 12-week treatment period, and a 2-week follow-up period.
Will I receive the study drug (valbenazine) or a placebo?
KINECT-HD is a randomized, double-blind, placebo-controlled Study. This means that participants will be randomly selected (like the flip of a coin) to receive the valbenazine or placebo. The placebo looks like valbenazine, but it does not contain any active medicine.
Site staff administering the study drug and conducting assessments of participants will not know whether the participant is receiving valbenazine or placebo. However, in case of emergency, the Clinical Investigator can obtain this information.
Is participant consent required for this study?
Yes. All participants must provide their written informed consent before being screened and participating in the study.
How do I find a study center site and enroll?
The KINECT-HD study is being conducted by the Huntington Study Group on behalf of Neurocrine Biosciences, Inc. Interested participants are encouraged to speak with their doctor about the study and may contact the Huntington Study Group to find the nearest participating site.
Toll-free phone (North America): 800-487-7671
Email: info@hsglimited.org