Ongoing, recruitingTherapeutic use (Phase IV)Interventional

TOXSIALO-TRIAL : Evaluation of the long-term efficacy of the injection of botulinum toxin A into the salivary glands versus scopolamine patches in the treatment of drooling in children over 4 years old with cerebral palsy.

This study, called the TOXSIALO-TRIAL, is for children over 4 years old who have cerebral palsy and dribble excessively. Dribbling, or drooling, can be a real problem for these children and their families. Researchers are comparing two different treatments: a special botox injection into the glands that make saliva, and a patch (called SCOPODERM) that can be placed on the skin. The main goal is to find out which treatment works better over 15 months to reduce the amount of dribbling and improve the child's quality of life. This is a "Phase IV" study, meaning it's looking at how well these treatments work in real-world settings after they've already been approved for use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospices Civils De Lyon

Enrolment target

132

Start

26 Jul 2024

Cerebral palsy with pathological drooling

What is this study about?

Many children with cerebral palsy experience a condition called excessive dribbling, often called drooling. This can be more than just a nuisance; it can lead to skin problems, mouth infections, and sometimes even breathing difficulties. It can also affect how children interact with others and make daily life more challenging for them and their families.

This study, called the TOXSIALO-TRIAL, is looking at two ways to help reduce dribbling in children over 4 with cerebral palsy. One treatment involves a special injection of botox into the glands that produce saliva. Botox works by temporarily relaxing muscles, and in this case, it aims to reduce how much saliva the glands make. The other treatment uses a patch, called SCOPODERM TTS, which releases a medicine over a few days to help dry up saliva production. The aim is to see how effective and safe both methods are over a longer period.

The researchers will follow children for 15 months to understand the effect of these treatments. They'll be checking not just how much dribbling reduces, but also how it impacts the child's comfort, health, and daily activities. This is important information because it helps doctors and families make the best choices for treating excessive dribbling.

Key takeaways

Compares botox injections versus a patch for dribbling in children with cerebral palsy.
Aims to reduce dribbling and improve quality of life.
Study lasts for 15 months with regular check-ups.
Open to children over 4 years old with cerebral palsy and excessive dribbling.
Will track dribbling severity, health issues, and side effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically designed for children who have cerebral palsy and experience excessive dribbling, sometimes called drooling.

To be considered for this study, your child must be over 4 years old. Both boys and girls can take part.

More detailed checks will happen if you and your child show an interest, to ensure the study is safe and appropriate for them.

Quick self-check

Is your child over 4 years old?
Does your child have cerebral palsy?
Does your child experience excessive dribbling (drooling)?
Are you able to attend regular clinic appointments for 15 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they would be assigned to receive either the botox injection or the SCOPODERM patch. The study will last for 15 months. During this time, your child will have regular visits to the clinic to check on their progress and health. These visits will likely happen at 1, 3, 6, 9, 12, and 15 months after starting the treatment.

At these visits, the medical team will assess your child's dribbling using a special scoring system. They will also ask about how many bibs your child uses each day, and if there have been any health issues, like chest infections, related to their dribbling. The team will also keep track of any side effects and any other medicines your child is taking.

The injections or patch applications would be part of these visits, and the team would guide you through everything involved.

Potential risks and benefits

Taking part in a study like this could potentially help reduce your child's dribbling, which might improve their comfort, health, and quality of life. However, as with any medical treatment, there's a chance of side effects. For example, the botox injection might cause some temporary weakness in nearby muscles, or the patch could cause skin irritation or other effects. The research team will carefully monitor your child for any side effects and will explain these in detail. It's very important to remember that participating is completely voluntary, and you are free to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

—
France

Common questions

What is 'cerebral palsy with pathological drooling'?

It means a child has cerebral palsy and also dribbles much more than is typical, to the point where it affects their health or daily life.

What is botulinum toxin A (Botox)?

It's a medicine that can be injected to temporarily relax certain muscles or reduce the activity of glands, like those that make saliva.

What are scopolamine patches (SCOPODERM TTS)?

These are patches placed on the skin that slowly release medicine to help dry up saliva and reduce dribbling.

What does 'primary endpoint' mean?

It's the main thing the researchers are looking at to decide if a treatment works. In this study, it's how much the dribbling improves over 15 months.

What is a 'Phase IV' study?

This means the treatments are already approved for use, and the study is looking at how well they work in a larger group of people over a longer time, in real-world settings.