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1 clinical trial in this condition
Study on Valbenazine for Treating Dyskinesia in Children and Adults with Cerebral Palsy
BelgiumIn short
Athetosis is a movement disorder characterized by involuntary, slow, writhing movements. Currently, there is 1 ongoing clinical trial investigating treatment options for this condition. This trial focuses on testing valbenazine, a medication aimed at reducing involuntary movements in people with dyskinesia due to cerebral palsy.
This trial is investigating the effectiveness and safety of valbenazine in treating involuntary movements in people with cerebral palsy. The condition being studied, dyskinesia due to cerebral palsy, involves jerky, dance-like movements that are difficult to control.
Main inclusion criteria: Participants must have a confirmed diagnosis of dyskinesia due to cerebral palsy, with choreiform movements. They must be between 4 and 17 years old, and their medical condition should be stable. Both males and females can participate.
Main exclusion criteria: People who do not have dyskinesia due to cerebral palsy or who do not experience choreiform movements cannot participate. Participants must fall within the specified age range and belong to the designated trial groups.
Focus and goal: The primary goal of this study is to measure changes in involuntary movements using the Total Maximal Chorea score from the start of treatment through weeks 12 and 14. Secondary assessments include evaluating improvement in overall severity of symptoms, changes in different types of movement disorders, patient and caregiver impressions of improvement, pain levels, and motor function scores. The study aims to understand whether valbenazine can effectively reduce involuntary movements and improve daily functioning for children and adults with this condition.
Investigational drug: Valbenazine is the medication being tested in this trial. It is taken orally as a capsule and works by selectively blocking a protein called vesicular monoamine transporter 2 (VMAT2). This action helps reduce the release of dopamine in the brain, which in turn helps control involuntary movements. The study follows a double-blind design, meaning neither participants nor researchers know who receives the actual medication or a placebo, ensuring unbiased results.
The trial began recruiting participants in October 2023 and is expected to conclude by January 2026. Throughout the study, healthcare professionals will closely monitor participants to assess both the effectiveness of the treatment and its safety profile.
Currently, there is one active clinical trial addressing involuntary movements associated with cerebral palsy. This study is being conducted across multiple European countries, including Spain, Poland, Belgium, Italy, and Portugal, indicating a coordinated international effort to find treatment options for this condition. The trial focuses specifically on valbenazine, a VMAT2 inhibitor, which represents a targeted pharmacological approach to managing choreiform movements. The study includes both children and adolescents, reflecting the need for treatment options across different age groups affected by this condition. The comprehensive assessment approach, including multiple scoring systems and both clinical and patient-reported outcomes, demonstrates a thorough evaluation of treatment effectiveness and its impact on quality of life.
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