Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Key facts
- Where
- Aurora, Baltimore, Boston, Chicago, Cincinnati, Columbus, Dallas, Farmington Hills, Fort Worth, Gulf Breeze, Houston, Miami, New York, Oklahoma City, Orlando, Portland, Saint Paul, San Diego, and Stamford, United StatesSee the 19 sites
- Phase
- Phase 3
Where in United States
- Aurora, ColoradoHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Columbus, OhioHospital not named in the registryNo longer taking part
- Dallas, TexasHospital not named in the registryNo longer taking part
- Farmington Hills, MichiganHospital not named in the registryNo longer taking part
- Fort Worth, TexasHospital not named in the registryNo longer taking part
- Gulf Breeze, FloridaHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- Miami, FloridaHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
- Orlando, FloridaHospital not named in the registryNo longer taking part
- Portland, OregonHospital not named in the registryNo longer taking part
- Saint Paul, MinnesotaHospital not named in the registryNo longer taking part
- San Diego, CaliforniaHospital not named in the registryNo longer taking part
- Stamford, ConnecticutHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- Neurocrine Biosciences
- Trial code
- NCT05206513EU 2022-502713-29-00
- Record updated
- 29 April 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Have a clinical diagnosis or history of dyskinesia due to condition other than CP; Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities; Participants will be excluded from the study if they meet any of the following criteria:; Are pregnant or breastfeeding; Is a substance abuser of any compound.