In short
This article provides information about ongoing clinical trials for choreoathetosis, a movement disorder characterized by involuntary, dance-like movements. Currently, there is 1 clinical trial underway investigating treatment options for this condition. The trial is focused on testing Valbenazine for treating dyskinesia in people with cerebral palsy across multiple European countries.
Clinical trial locations
- Belgium
- Italy
- Poland
- Portugal
- Spain
Study on Valbenazine for Treating Dyskinesia in Children and Adults with Cerebral Palsy
This clinical trial is investigating Valbenazine, an oral medication, for treating involuntary movements in people with cerebral palsy. The study is examining both children and adults who experience dyskinesia, which refers to uncontrolled, dance-like movements that can interfere with daily activities.
Who can participate:
- Patients must have a confirmed diagnosis of dyskinesia due to cerebral palsy, with jerky or dance-like movements called choreiform movements
- Participants can be children and teenagers between 4 and 17 years old
- The patient's medical condition must be stable and not expected to worsen during the study
- Both males and females can participate
Who cannot participate:
- Patients without dyskinesia caused by cerebral palsy
- Those who do not experience choreiform movements
- Individuals outside the specified age range
- Those who do not meet the specific clinical trial group criteria
What the trial involves:
The main goal of this trial is to evaluate how effective Valbenazine is at reducing involuntary movements. Participants will be randomly assigned to receive either the active medication or a placebo, which looks identical but contains no active ingredient. Neither the participants nor the researchers will know who receives which treatment during the study, ensuring unbiased results.
The medication is taken orally in capsule form. The primary measurement focuses on changes in the Total Maximal Chorea score, which assesses the severity of involuntary movements, from the beginning of the study to weeks 12 and 14. This helps determine whether the treatment successfully reduces these movements.
The trial also evaluates several other aspects, including changes in overall severity of the condition, movement disorder rating scales, pain levels, and improvements as reported by patients and their caregivers. Healthcare professionals will monitor participants throughout the study to assess both the effectiveness and safety of Valbenazine.
About Valbenazine:
Valbenazine works by selectively inhibiting a protein called vesicular monoamine transporter 2, or VMAT2. This action reduces the release of dopamine in the brain, which helps control involuntary movements. The medication is being tested to determine if it is both safe and tolerable for treating dyskinesia in both children and adults with cerebral palsy.
The study began recruiting participants in October 2023 and is expected to conclude by January 2026. The trial is being conducted across five European countries: Spain, Poland, Belgium, Italy, and Portugal.
Summary
Currently, there is one ongoing clinical trial for choreoathetosis, specifically focusing on dyskinesia associated with cerebral palsy. The trial is testing Valbenazine, a VMAT2 inhibitor that aims to reduce involuntary, dance-like movements. The study is notable for its international scope across five European countries and its inclusion of both pediatric and adult patients. The trial uses a rigorous double-blind, placebo-controlled design to ensure reliable results about the medication's effectiveness and safety.
