Summary:
Research study for individuals 6 to 70 years of age with involuntary movements that are difficult to control (dyskinesia) due to cerebral palsy (DCP).
Study Purpose:
The purpose of the Kinect-DCP Study is to determine if the study drug, called valbenazine, is safe to use and if it helps to improve involuntary movements that are difficult to control due to CP.
The total length of participation is approximately 56 weeks. This includes a 6-week screening period, a 14-week treatment period during which participants will receive either the study drug or placebo, a 2-week washout period during which participants will not receive the study drug or placebo, a 32-week treatment period during which participants will receive the study drug, and a final 2-week washout period.
Individuals will be evaluated to determine their eligibility to participate. Those who qualify will receive the study drug or placebo, as well as study-related medical exams and study-related laboratory tests, all at no cost. Compensation for time and travel may be available. All participants who are initially assigned to receive the placebo will be switched to the study drug at a certain point in the study.
Eligibility Criteria:
Eligible participants must:
- Be a child, adolescent, or adult 6 to 70 years of age
- Have a confirmed diagnosis of dyskinesia (involuntary movements) due to CP, with choreiform movements
- Not have involuntary movements due to conditions other than CP
Other protocol-defined inclusion and exclusion criteria may apply.