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

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.

Conditions

Dyskinesia, Cerebral Palsy

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Dyskinesia
Intervention / Treatment

-

Contacts and Locations

San Diego

Neurocrine Clinical Site, San Diego, California, United States, 92123

Aurora

Neurocrine Clinical Site, Aurora, Colorado, United States, 80045

Stamford

Neurocrine Clinical Site, Stamford, Connecticut, United States, 06905

Gulf Breeze

Neurocrine Clinical Site, Gulf Breeze, Florida, United States, 32561

Miami

Neurocrine Clinical Site, Miami, Florida, United States, 33155

Augusta

Neurocrine Clinical Site, Augusta, Georgia, United States, 30912

Chicago

Neurocrine Clinical Site, Chicago, Illinois, United States, 60611

Baltimore

Neurocrine Clinical Site, Baltimore, Maryland, United States, 21205

Farmington Hills

Neurocrine Clinical Site, Farmington Hills, Michigan, United States, 48334

Grand Rapids

Neurocrine Clinical Site, Grand Rapids, Michigan, United States, 49503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy \[CP\]) with choreiform movements.
  • 2. Medical conditions are stable and expected to remain stable throughout the study.
  • 1. Are pregnant or breastfeeding.
  • 2. Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
  • 3. Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
  • 4. Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
  • 5. Is a substance abuser of any compound.
  • 6. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.

Ages Eligible for Study

6 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurocrine Biosciences,

Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

2026-01