Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
NCT05206513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-04-29
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) with choreiform movements.
Conditions
- Dyskinesia
- Cerebral Palsy
Interventions
- DRUG
-
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
- DRUG
-
Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Sponsors & Collaborators
-
Neurocrine Biosciences
lead INDUSTRY
Principal Investigators
-
Clinical Development Lead · Neurocrine Biosciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-15
- Primary Completion
- 2025-10-16
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Belgium
- Brazil
- Israel
- Italy
- Mexico
- Poland
- Portugal
- Spain
Study Locations
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