Clinical Trial TitleA phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of valbenazine for the treatment of chorea associated with Huntington’s disease.
National Clinical Trial Number:NCT04102579
Clinical Trial Protocol Description:
A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of valbenazine to treat chorea associated with Huntington's disease. Participation lasts approximately 18 weeks (9 visits) during which time participants will take study pills and undergo ECGs, blood draws, surveys, and health assessments. The study may require potential participants have a caregiver to accompany them to study visits.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a clinical diagnosis of Huntington disease (HD) with chorea.
- Are able to walk, with or without the assistance of a person or device.
- Agree to use hormonal or two forms of nonhormonal contraception consistently during study if you are of childbearing potential.
- Are able to read and understand English.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of prior VMAT2 inhibitor therapy.
- Have an unstable or serious medical or psychiatric illness.
- Have received gene therapy at any time.
- Have a significant risk of suicidal behavior.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.