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ACTIVE NOT RECRUITING
NCT05206513
PHASE3

Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy

Sponsor: Neurocrine Biosciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2022-04-15

Completion Date

2026-06

Last Updated

2025-08-01

Healthy Volunteers

No

Interventions

DRUG

Placebo

Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube

DRUG

Valbenazine

Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube

Locations (38)

Neurocrine Clinical Site

San Diego, California, United States

Neurocrine Clinical Site

Aurora, Colorado, United States

Neurocrine Clinical Site

Stamford, Connecticut, United States

Neurocrine Clinical Site

Gulf Breeze, Florida, United States

Neurocrine Clinical Site

Miami, Florida, United States

Neurocrine Clinical Site

Orlando, Florida, United States

Neurocrine Clinical Site

Chicago, Illinois, United States

Neurocrine Clinical Site

Baltimore, Maryland, United States

Neurocrine Clinical Site

Boston, Massachusetts, United States

Neurocrine Clinical Site

Farmington Hills, Michigan, United States

Neurocrine Clinical Site

Saint Paul, Minnesota, United States

Neurocrine Clinical Site

New York, New York, United States

Neurocrine Clinical Site

Cincinnati, Ohio, United States

Neurocrine Clinical Site

Columbus, Ohio, United States

Neurocrine Clinical Site

Oklahoma City, Oklahoma, United States

Neurocrine Clinical Site

Portland, Oregon, United States

Neurocrine Clinical Site

Dallas, Texas, United States

Neurocrine Clinical Site

Fort Worth, Texas, United States

Neurocrine Clinical Site

Houston, Texas, United States

Neurocrine Clinical Site

Buenos Aires, Argentina

Neurocrine Clinical Site

Buenos Aires, Argentina

Neurocrine Clinical Site

Brussels, Belgium

Neurocrine Clinical Site

Brasília, Brazil

Neurocrine Clinical Site

Curitiba, Brazil

Neurocrine Clinical Site

Porto Alegre, Brazil

Neurocrine Clinical Site

Porto Alegre, Brazil

Neurocrine Clinical Site

Ẕerifin, Israel

Neurocrine Clinical Site

Calambrone, Italy

Neurocrine Clinical Site

Milan, Italy

Neurocrine Clinical Site

Aguascalientes, Mexico

Neurocrine Clinical Site

Gdansk, Poland

Neurocrine Clinical Site

Krakow, Poland

Neurocrine Clinical Site

Oświęcim, Poland

Neurocrine Clinical Site

Lisbon, Portugal

Neurocrine Clinical Site

Lisbon, Portugal

Neurocrine Clinical Site

Porto, Portugal

Neurocrine Clinical Site

Barcelona, Spain

Neurocrine Clinical Site

Madrid, Spain