Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
About the study
The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy [CP]) with choreiform movements.
- Medical conditions are stable and expected to remain stable throughout the study.
EXCLUSION CRITERIA
Key Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria:
- Are pregnant or breastfeeding.
- Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
- Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
- Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
- Is a substance abuser of any compound.
- Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Dyskinesia,Cerebral Palsy
Age
6 - 70
Phase
PHASE3
Participants Needed
80
Est. Completion Date
Jan 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Neurocrine Biosciences
ClinicalTrials.gov NCT Identifier
NCT05206513
Study Number
NBI-98854-DCP3018
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