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Evaluating Valbenazine for treating dyskinesia in cerebral palsy

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

PHASE3 · Neurocrine Biosciences · NCT05206513

This study tests if the medication valbenazine can help reduce involuntary movements in people with dyskinesia caused by cerebral palsy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment80 (estimated)
Ages6 Years to 70 Years
SexAll
SponsorNeurocrine Biosciences (industry)
Locations43 sites (San Diego, California and 42 other locations)
Trial IDNCT05206513 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, in improving chorea associated with dyskinesia due to cerebral palsy. Participants, both pediatric and adult, will be randomly assigned to receive either valbenazine or a placebo. The primary focus is on measuring improvements in choreiform movements over the course of the study. The study is designed to ensure that participants have stable medical conditions throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are individuals with a medically confirmed diagnosis of dyskinesia due to cerebral palsy who exhibit choreiform movements.

Not a fit: Patients with dyskinesia from conditions other than cerebral palsy or those with significant medical issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with dyskinesia due to cerebral palsy by reducing involuntary movements.

How similar studies have performed: While this approach is relatively novel, previous studies on VMAT2 inhibitors have shown promise in treating movement disorders, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

San Diego, California and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Dyskinesia, Cerebral Palsy, Vesicular monoamine transporter 2 inhibitor, Neurocrine, Valbenazine, NBI-98854, Dystonia, Chorea

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.