Study to assess Valbenazine for Dyskinesia due to Cerebral Palsy (H-52420)
Description
The purpose of the Kinect-DCP Study is to determine if the study drug, called valbenazine, is safe to use and if it helps with the treatment of involuntary movements that are difficult to control (dyskinesia) due to cerebral palsy (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. All participants who are initially assigned to receive 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 18 years of age
- Have a confirmed diagnosis of dyskinesia (involuntary movements) due to CP
- Not have involuntary movements due to conditions other than CP
Other protocol-defined inclusion and exclusion criteria may apply.
Contact
Phone 1: 832–824–3968
IRB: H-52420
Status:
Active
Created: