Trials / Active Not Recruiting
Active Not RecruitingNCT05206513
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 6 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube |
| DRUG | Valbenazine | Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube |
Timeline
- Start date
- 2022-04-15
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2022-01-25
- Last updated
- 2025-08-01
Locations
38 sites across 10 countries: United States, Argentina, Belgium, Brazil, Israel, Italy, Mexico, Poland, Portugal, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05206513. Inclusion in this directory is not an endorsement.