BridgeMD
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.
EU CTIS ID: 2024-512160-58-00
What this study is testing
To evaluate and compare the efficacy after 15 months of a “standardized rehabilitation guidance” treatment, associated with the injection of botulinum toxin (Botox®) in the salivary glands, compared to a “standardized rehabilitation guidance” treatment associated with the use of a scopolamine patch (Scopoderm®), on the degree and impact of drooling for children with cerebral palsy aged 4 years and over with pathological drooling.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged 4 to 17 years old
- Cerebral palsy (with permanent tonus and posture disorder caused by a stable (non-progressive/non-degenerative) brain injury, congenital or acquired before the age of 2 years, regardless of the origin of the lesion) and with disabling drooling
- Significant impact of drooling on the children (DIS score ≥40)
- Affiliated or beneficiary of a social security scheme
- At least one of the parents understanding and speaking French
- Written consent form signed by both parents
You likely can't join if
- Previous history of surgery for drooling
- Untreated severe or acute dental inflammatory condition (dental caries, gingivitis…)
- Epileptic encephalopathies and Rett syndromes
- Injection of botulinum toxin (all locations) in the 3 months prior to the inclusion
- Treatment by scopolamine patch (Scopoderm®) or other anticholinergic (Artane®, etc.) in the 7 days prior to inclusion
- Contraindication to the anesthetic or sedation
See the full eligibility criteria
- Aged 4 to 17 years old
- Cerebral palsy (with permanent tonus and posture disorder caused by a stable (non-progressive/non-degenerative) brain injury, congenital or acquired before the age of 2 years, regardless of the origin of the lesion) and with disabling drooling
- Significant impact of drooling on the children (DIS score ≥40)
- Affiliated or beneficiary of a social security scheme
- At least one of the parents understanding and speaking French
- Written consent form signed by both parents
- Absence of known current pregnancy and breastfeeding
- Previous history of surgery for drooling
- Untreated severe or acute dental inflammatory condition (dental caries, gingivitis…)
- Epileptic encephalopathies and Rett syndromes
- Injection of botulinum toxin (all locations) in the 3 months prior to the inclusion
- Treatment by scopolamine patch (Scopoderm®) or other anticholinergic (Artane®, etc.) in the 7 days prior to inclusion
- Contraindication to the anesthetic or sedation
- Contraindication to one of the treatments studied (glaucoma, myasthenia, uretroprostatic disorders)
- Injection site infection
- Patients without gastrostomy, with a swallowing disorder (to saliva) or absence of spontaneous swallowing reflex not investigated by an ENT specialist (by nasoscopy or other)
- On-going or programmed orthodontic treatment over the study period
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.