Status:
ACTIVE_NOT_RECRUITING
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Dyskinesia
Cerebral Palsy
Eligibility:
All Genders
6-70 years
Phase:
PHASE3
Brief Summary
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) wi...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05206513
Start Date
April 15 2022
End Date
June 1 2026
Last Update
August 1 2025
Active Locations (38)
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1
Neurocrine Clinical Site
San Diego, California, United States, 92123
2
Neurocrine Clinical Site
Aurora, Colorado, United States, 80045
3
Neurocrine Clinical Site
Stamford, Connecticut, United States, 06905
4
Neurocrine Clinical Site
Gulf Breeze, Florida, United States, 32561