Ongoing Clinical Trials for Cerebral Palsy
Currently, there are 3 clinical trials investigating treatments for cerebral palsy. These studies are exploring different approaches to managing symptoms such as excessive drooling, muscle spasticity in the legs, and involuntary movements. The trials are being conducted across several European countries and involve both children and adolescents with this condition.
Clinical trial locations
- Belgium
- France
- Italy
- Latvia
- Poland
- Portugal
- Spain
Study on Botulinum Toxin A and Hyoscine for Treating Drooling in Children Over 4 with Cerebral Palsy
This trial is evaluating treatments for excessive drooling in children aged 4 years and older. The study compares two different approaches: injections of botulinum toxin type A (commonly known as Botox) directly into the salivary glands, and the use of scopolamine patches (known as Scopoderm) applied to the skin. The main focus is to assess how well these treatments reduce drooling over a 15-month period.
Main inclusion criteria: Children must be between 4 and 17 years old and have a confirmed diagnosis of the condition with disabling drooling that significantly impacts their daily life. The drooling severity must score 40 or higher on the DIS scale, which measures the impact of drooling. At least one parent must speak French, and both parents must provide written consent for their child to participate. The child must also be affiliated with a social security scheme.
Main exclusion criteria: Children under 4 years old cannot participate. Those who have allergies to botulinum toxin or scopolamine are excluded, as are children who cannot follow the standardized rehabilitation guidance that is part of the study. Children who are unable to receive injections in their salivary glands or who are participating in another clinical trial at the same time are also excluded. Any medical conditions that would make participation unsafe, as determined by study doctors, will result in exclusion.
Investigational drugs: The study uses two treatments. Botulinum Toxin A (Botox) is injected into the salivary glands to decrease saliva production by blocking nerve signals that stimulate saliva flow. Scopolamine Patch (Scopoderm) is applied to the skin and works by blocking certain nerve receptors to reduce saliva production. Both treatments aim to help manage excessive drooling.
Study on the Effectiveness and Safety of NT 201 for Treating Lower Limb Spasticity in Children and Adolescents with Cerebral Palsy
This study focuses on treating lower limb spasticity, a condition where leg muscles are continuously contracted, making movement difficult. The trial tests NT 201, also known as IncobotulinumtoxinA, which is a type of botulinum toxin designed to help relax tight muscles. The study aims to determine whether a single injection of NT 201 can improve muscle stiffness in the legs of children and adolescents between the fourth and sixth week after treatment.
Main inclusion criteria: Participants must be between 2 and 17 years old and have bilateral, symmetrical pes equinus, meaning both feet point downwards due to lower limb spasticity. They must have a Modified Ashworth Scale score of 2 or higher, which measures muscle tightness in the calf muscles. Children can have any level of movement ability according to the Gross Motor Function Classification System. Both boys and girls can participate.
Main exclusion criteria: Children and adolescents who do not have spasticity in their lower limbs caused by the condition cannot participate. Children younger than 2 years old are excluded from the study.
Investigational drug: NT 201 is administered through an injection into the affected muscles. It works by blocking nerve signals that cause muscles to contract, helping to reduce muscle stiffness. The medication is being studied for its effectiveness in improving movement and reducing leg muscle tightness in young patients.
Study on Valbenazine for Treating Dyskinesia in Children and Adults with Cerebral Palsy
This trial investigates a condition called dyskinesia, which involves involuntary, jerky movements that can occur in people with the condition. The study is testing a medication called Valbenazine, taken orally as a capsule, to see if it can improve these involuntary movements. The trial is designed as a double-blind study, meaning neither participants nor researchers know who is receiving the actual medication or a placebo during the initial phase, ensuring unbiased results.
Main inclusion criteria: Patients must have a medically confirmed diagnosis of dyskinesia characterized by choreiform movements, which are jerky or dance-like involuntary movements. The patient’s medical conditions should be stable and expected to remain stable throughout the study. Participants can be male or female and must be between 4 and 17 years old.
Main exclusion criteria: Patients who do not have dyskinesia or who do not experience choreiform movements cannot participate. Those who are not within the specified age range for the study are excluded. The study is designed for specific clinical trial groups, and participants must belong to these groups.
Investigational drug: Valbenazine is taken orally in capsule form. It works by selectively inhibiting VMAT2, a protein in the brain, which reduces the release of dopamine and helps control involuntary movements. The trial evaluates how well Valbenazine reduces these movements and assesses its safety and tolerability in both children and adults.
Summary
These three clinical trials represent diverse approaches to managing different symptoms associated with cerebral palsy. One trial focuses on excessive drooling using either botulinum toxin injections or scopolamine patches, taking place in France. Another addresses lower limb spasticity with NT 201 injections and is being conducted in Poland and Latvia. The third trial, which has the widest geographical reach across Spain, Poland, Belgium, Italy, and Portugal, investigates Valbenazine for treating involuntary movements.
A notable observation is that all three trials target specific symptoms rather than the underlying condition itself, reflecting the current approach to symptom management in cerebral palsy. The trials include children and adolescents across different age ranges, with participants as young as 2 years old and extending up to 17 years. Two of the three trials utilize botulinum toxin-based treatments, highlighting the continued interest in this class of medications for managing various symptoms associated with the condition.
