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

Launched by NEUROCRINE BIOSCIENCES · Jan 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called valbenazine to see if it can help improve abnormal movements, known as dyskinesia, in people with cerebral palsy. Dyskinesia can cause uncontrollable movements, and the trial aims to find out if valbenazine is more effective than a placebo (a dummy treatment) in reducing these movements in both children and adults who are diagnosed with this condition.

To join the study, participants need to have a confirmed diagnosis of cerebral palsy with these specific involuntary movements. They should also be in stable health, meaning their other medical conditions should not be changing during the trial. However, certain individuals, like those who are pregnant, have a different type of dyskinesia, or have specific medical issues, won’t be eligible to participate. Those who take part can expect to receive either the medication or the placebo and will be monitored for safety and how well the treatment works. This study is currently recruiting participants, and it’s an important step in finding better treatments for dyskinesia related to cerebral palsy.

Gender

ALL

Eligibility 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.