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Study on Botulinum Toxin A and Hyoscine for Treating Drooling in Children Over 4 with Cerebral Palsy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on evaluating treatments for children aged 4 years and older who have cerebral palsy and experience excessive drooling. The study compares two treatments: the injection of botulinum toxin type A (commonly known as Botox) into the salivary glands and the use of scopolamine patches (known as Scopoderm). Both treatments aim to reduce drooling, which can be a significant issue for children with cerebral palsy.

The purpose of the study is to assess the long-term effectiveness of these treatments over a period of 15 months. Participants will receive either the Botox injections or the Scopoderm patches, along with a standardized rehabilitation guidance. The study will monitor the degree and impact of drooling at various intervals, including 1, 3, 6, 9, 12, and 15 months, to determine how well each treatment works in reducing drooling.

Throughout the study, researchers will also observe any side effects or complications that may arise from the treatments. This includes tracking the number of hospitalizations due to drooling-related issues, the use of antibiotics for infections, and any adverse events experienced by the participants. The study aims to provide valuable insights into the most effective treatment for managing drooling in children with cerebral palsy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The trial begins with the administration of either botulinum toxin type A or scopolamine patches to manage drooling in children with cerebral palsy.
Botulinum toxin type A is injected directly into the salivary glands. This is known as intraglandular use.
Scopolamine patches are applied to the skin. This is referred to as cutaneous use.
The choice between these treatments is determined at the start of the trial.
Step 2
Monitoring and assessment
The effectiveness of the treatment is evaluated over a period of 15 months.
Assessments occur at 1, 3, 6, 9, 12, and 15 months after the start of the treatment.
The degree and impact of drooling are measured using the DIS scale.
The quantity of saliva is assessed by counting the average number of bibs used per day over a week.
Step 3
Safety and side effects evaluation
The trial monitors for any adverse events, which are unwanted effects that may occur during treatment.
The nature, frequency, and intensity of these events are recorded at each assessment point.
The trial also tracks any hospitalizations for pulmonary infections and prescriptions for antibiotics related to bronchial infections.
Step 4
Treatment adjustments
Adjustments to the treatment, such as dose modifications or reinjections, may be made based on the patient's response.
These adjustments are documented and justified at each assessment point.
Step 5
Conclusion of the trial
The trial concludes after 15 months of treatment.
The final assessment includes a comprehensive evaluation of the treatment's long-term efficacy and safety.

Who can join the trial?

8 criteria

Children must be between the ages of 4 and 17 years old.
Children must have **cerebral palsy**, which is a condition that affects movement and posture due to a brain injury that does not get worse over time. This injury must have occurred before the child was 2 years old.
Children must have **disabling drooling**, which means drooling that significantly affects their daily life.
The drooling must have a significant impact, measured by a **DIS score** of 40 or higher. The DIS score is a way to measure how much drooling affects the child.
The child must be affiliated with or a beneficiary of a social security scheme.
At least one parent must understand and speak French.
Both parents must sign a written consent form, agreeing to the child's participation in the study.
The child must not be currently pregnant or breastfeeding.

Who cannot join the trial?

7 criteria

Children under 4 years old cannot participate.
Children who do not have cerebral palsy with **pathological drooling** cannot participate. **Pathological drooling** means drooling that is more than usual and causes problems.
Children who are not able to follow the **standardized rehabilitation guidance** cannot participate. This is a specific type of treatment plan that needs to be followed.
Children who have allergies or reactions to **botulinum toxin** (Botox®) or **scopolamine** (Scopoderm®) cannot participate. **Botulinum toxin** is a medicine used to reduce drooling, and **scopolamine** is a patch that helps with drooling.
Children who are not able to have injections in their **salivary glands** cannot participate. **Salivary glands** are the parts of the mouth that make saliva, or spit.
Children who are part of another clinical trial at the same time cannot participate.
Children who have medical conditions that the study doctors think would make it unsafe for them to participate cannot participate.

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Verified sites

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Assistance Publique Hopitaux De Marseille
Marseille, France
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CHU Grenoble Alpes
La Tronche, France
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Centre Hospitalier Lyon Sud
Pierre Benite, France

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Investigated drugs

Botulinum Toxin A (Botox®)
is used in this trial to help reduce drooling in children with cerebral palsy. It is injected into the salivary glands to decrease saliva production, which can help manage excessive drooling.
Scopolamine Patch (Scopoderm®)
is another treatment option in the trial. It is a patch that is placed on the skin and works by blocking certain nerve signals to reduce saliva production, thereby helping to control drooling in children with cerebral palsy.

What is already known about the treatment

Botulinum Toxin A
This medication is administered through injections directly into the salivary glands. It is currently being studied for its effectiveness in reducing drooling in children over 4 years old with cerebral palsy. The main therapeutic indication is to manage excessive drooling, which can be a significant issue for these patients. At the molecular level, Botulinum Toxin A works by blocking the release of acetylcholine, a neurotransmitter that stimulates saliva production, thereby reducing saliva flow. It is classified as a neurotoxin and is widely used in various medical and cosmetic applications.
Scopolamine
This medication is applied as a patch on the skin, typically behind the ear. It is being evaluated for its ability to reduce drooling in children with cerebral palsy. The primary therapeutic use is to manage excessive saliva production. Scopolamine works by blocking the action of acetylcholine on muscarinic receptors, which decreases saliva secretion. It is classified as an anticholinergic agent and is commonly used to prevent nausea and motion sickness.

Investigated diseases

Cerebral palsy with pathological drooling – Cerebral palsy is a group of disorders that affect movement and muscle tone or posture, caused by damage that occurs to the immature brain as it develops, most often before birth. Pathological drooling in cerebral palsy is characterized by excessive saliva production and difficulty in controlling saliva flow, leading to drooling. This condition can cause social and hygiene issues, as well as skin irritation around the mouth and chin. The drooling is often due to poor muscle control in the face and mouth, which is a common symptom in individuals with cerebral palsy. Over time, the severity of drooling can vary, and it may be influenced by factors such as posture, head control, and oral motor function.