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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

Non Recruiting
6-70 years
All
Phase 3

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Overview

The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in participants aged 6 to 70 years who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.

Eligibility

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 solids, unless medications can be administered via a gastrostomy 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 details
    Dyskinesia
    Cerebral Palsy

NCT05206513

Neurocrine Biosciences

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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