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 participants aged 6 to 70 years 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 solids, unless medications can be administered via a gastrostomy 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
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Dyskinesia,Cerebral Palsy
Age (in years)
6 - 70
Phase
Phase 3
Participants needed
80
Est. Completion Date
Aug 31, 2024
Treatment type
Interventional
Sponsor
Neurocrine Biosciences
ClinicalTrials.gov identifier
NCT05206513
Study number
NBI-98854-DCP3018
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