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Completed

NCT Number: NCT05206513

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.

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Key information

Conditions

Dyskinesia Athetosis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Chorea Dyskinesias Dystonia Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurocrine Clinical Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy [CP]) with choreiform movements.
  • 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:

  • Are pregnant or breastfeeding.
  • Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
  • Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
  • Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
  • Is a substance abuser of any compound.
  • Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.

Treatment and study plan

Placebo

Drug

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

Valbenazine

Drug

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

Other names: NBI-98854

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in the Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 14

    Time frame: Baseline, Week 14

  2. 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

  3. 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

  4. Patient Global Impression of Improvement (PGI-I) Score at Week 14

    Time frame: Week 14

  5. Caregiver Global Impression of Improvement (CaGI-I) Score at Week 14

    Time frame: Week 14

  6. Clinical Global Impression of Improvement (CGI-I) Score at Week 14

    Time frame: Week 14

  7. Goal Attainment Score at Week 14 Using the Goal Attainment Scale (GAS)

    Time frame: Week 14

  8. Change in Pain Assessment from Baseline to Week 14 Using the Faces Pain Scale-Revised (FPS-R)

    Time frame: Baseline, Week 14

  9. 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

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 25, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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