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.
- Conditions
- Cerebral palsy with pathological droolingMedDRA version: 20.1Level: PTClassification code: 10008129Term: Cerebral palsy Class: 100000004850Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-512160-58-00
- Lead Sponsor
- Hospices Civils De Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method