Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Study Details
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Conditions: Dyskinesia, Cerebral Palsy
Study ID:
NEU99201 (NBI-98854-DCP3018)
Study Description
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.
Eligibility Requirements
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
- 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.
Principal Investigator
Migvis Monduy
More Information
To learn more visit: https://clinicaltrials.gov/study/NCT05206513.
This page was last updated on: June 11, 2025 12:32 PM