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

Last updated: March 27, 2025
Sponsor: Neurocrine Biosciences
Overall Status: Active - Recruiting

Phase

3

Condition

Dyskinesias

Cerebral Palsy

Cataplexy

Treatment

Valbenazine

Placebo

Clinical Study ID

NCT05206513
NBI-98854-DCP3018
EUCT
  • Ages 6-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder dueto cerebral palsy [CP]) with choreiform movements.

  2. Medical conditions are stable and expected to remain stable throughout the study.

Exclusion

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 viagastrostomy/gastrojejunostomy tube.

  4. Have any suicidal behavior or suicidal ideation in the year prior to screening or onDay 1.

  5. Is a substance abuser of any compound.

  6. Known history of long QT syndrome or cardiac tachyarrhythmia, or clinicallysignificant electrocardiogram (ECG) abnormalities.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Valbenazine
Phase: 3
Study Start date:
April 15, 2022
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Neurocrine Clinical Site

    Buenos Aires, C1425EFD
    Argentina

    Active - Recruiting

  • Neurocrine Clincial Site

    Ciudad Autónoma de Buenos Aires, C1060AAF
    Argentina

    Active - Recruiting

  • Neurocrine Clinical Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Neurocrine Clinical Site

    Brasília, 70684
    Brazil

    Active - Recruiting

  • Neurocrine Clinical Site

    Curitiba, 80250-060
    Brazil

    Active - Recruiting

  • Neurocrine Clinical Site

    Porto Alegre, 90050
    Brazil

    Active - Recruiting

  • Neurocrine Clinical Site

    Calambrone, 56128
    Italy

    Active - Recruiting

  • Neurocrine Clinical Site

    Gdańsk, 80-389
    Poland

    Active - Recruiting

  • Neurocrine Clinical Site

    Oswiecim, 32-600
    Poland

    Active - Recruiting

  • Neurocrine Clinical Site

    Lisboa, 1169-045
    Portugal

    Active - Recruiting

  • Neurocrine Clinical Site

    Barcelona, 08038
    Spain

    Active - Recruiting

  • Neurocrine Clinical Site

    Madrid, 28006
    Spain

    Active - Recruiting

  • Neurocrine Clinical Site

    San Sebastián, 20009
    Spain

    Active - Recruiting

  • Neurocrine Clinical Site

    San Diego, California 92123
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Gulf Breeze, Florida 32561
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Neurocrine Clinical Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    New York, New York 10003
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Dallas, Texas 75390-8857
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Neurocrine Clinical Site

    Houston, Texas 77030
    United States

    Active - Recruiting

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