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

April 23, 2026 updated by: Neurocrine Biosciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425EFD
        • Neurocrine Clinical Site
      • Buenos Aires, Argentina, C1060AAF
        • Neurocrine Clinical Site
  • Belgium
      • Brussels, Belgium, 1200
        • Neurocrine Clinical Site
  • Brazil
      • Brasília, Brazil, 70684-831
        • Neurocrine Clinical Site
      • Curitiba, Brazil, 80250-060
        • Neurocrine Clinical Site
      • Porto Alegre, Brazil, 90035-001
        • Neurocrine Clinical Site
      • Porto Alegre, Brazil, 90050-170
        • Neurocrine Clinical Site
  • Israel
      • Ẕerifin, Israel, 7030000
        • Neurocrine Clinical Site
  • Italy
      • Calambrone, Italy, 56128
        • Neurocrine Clinical Site
      • Milan, Italy, 3. 20162
        • Neurocrine Clinical Site
  • Mexico
      • Aguascalientes, Mexico
        • Neurocrine Clinical Site
  • Poland
      • Gdansk, Poland, 80-389
        • Neurocrine Clinical Site
      • Krakow, Poland, 30-539
        • Neurocrine Clinical Site
      • Oświęcim, Poland, 32-600
        • Neurocrine Clinical Site
  • Portugal
      • Lisbon, Portugal, 1169-045
        • Neurocrine Clinical Site
      • Lisbon, Portugal, 1649-035
        • Neurocrine Clinical Site
      • Porto, Portugal, 4050-651
        • Neurocrine Clinical Site
  • Spain
      • Barcelona, Spain, 08038
        • Neurocrine Clinical Site
      • Madrid, Spain, 28006
        • Neurocrine Clinical Site
  • United States
    • California
      • San Diego, California, United States, 92123
        • Neurocrine Clinical Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Neurocrine Clinical Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Neurocrine Clinical Site
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Neurocrine Clinical Site
      • Miami, Florida, United States, 33155
        • Neurocrine Clinical Site
      • Orlando, Florida, United States, 32806
        • Neurocrine Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Neurocrine Clinical Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Neurocrine Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Neurocrine Clinical Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Neurocrine Clinical Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Neurocrine Clinical Site
    • New York
      • New York, New York, United States, 10003
        • Neurocrine Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Neurocrine Clinical Site
      • Columbus, Ohio, United States, 43205
        • Neurocrine Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Neurocrine Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75390-8857
        • Neurocrine Clinical Site
      • Fort Worth, Texas, United States, 76104
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Neurocrine Clinical Site

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.

Eligibility Criteria

Ages Eligible for Study

6 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion 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.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo

Placebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.

Participants may opt to enter an open-label valbenazine treatment extension phase.
Drug: Placebo
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Drug: Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Other Names:
  • NBI-98854
Experimental: Valbenazine

Valbenazine dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.

Participants may opt to enter an open-label valbenazine treatment extension phase.
Drug: Valbenazine
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
Other Names:
  • NBI-98854

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Total Maximal Chorea (TMC) Score of the Unified Huntington Disease Rating Scale (UHDRS) from Baseline to the Average of the Week 12 and Week 14 assessments
Time Frame: Baseline, Week 12 and Week 14
Baseline, Week 12 and Week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 14
Time Frame: Baseline, Week 14
Baseline, Week 14
Change in the Movement Disorders - Childhood Rating Scale (MD-CRS) Part I Score from Baseline to the Average of the Week 12 and Week 14 Assessments
Time Frame: Baseline, Week 12 and Week 14
Baseline, Week 12 and Week 14
Change in the Total Maximal Dystonia (TMD) Score of the UHDRS from Baseline to the Average of the Week 12 and Week 14 Assessments
Time Frame: Baseline, Week 12 and Week 14
Baseline, Week 12 and Week 14
Patient Global Impression of Improvement (PGI-I) Score at Week 14
Time Frame: Week 14
Week 14
Caregiver Global Impression of Improvement (CaGI-I) Score at Week 14
Time Frame: Week 14
Week 14
Clinical Global Impression of Improvement (CGI-I) Score at Week 14
Time Frame: Week 14
Week 14
Goal Attainment Score at Week 14 Using the Goal Attainment Scale (GAS)
Time Frame: Week 14
Week 14
Change in Pain Assessment from Baseline to Week 14 Using the Faces Pain Scale-Revised (FPS-R)
Time Frame: Baseline, Week 14
Baseline, Week 14
Change in the UHDRS Total Motor Score (TMS) from Baseline to the Average of the Week 12 and Week 14 Assessments
Time Frame: Baseline, Week 12 and Week 14
Baseline, Week 12 and Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Actual)

October 16, 2025

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-98854-DCP3018
  • EUCT (Other Identifier: 2022-502713-29-00)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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