Evaluation of the efficacy of the injection of botulinum toxin A vs scopolamine patches in the treatment of drooling in children with cerebral palsy

Phase 1

Conditions: Children with cerebral palsy aged 4 years old and over, presenting a pathological drooling
MedDRA version: 20.1Level: PTClassification code 10008129Term: Cerebral palsySystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2021-000095-10-FR

Lead Sponsor: Hospices Civils de Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

•Aged 4 to 17 years old,
•Cerebral palsy (stable brain injury acquired before the age of 2 years), 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous history of surgery for drooling,
•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 month prior to inclusion,
•Contraindication to the anesthetic or sedation,
•Contraindication to one of the treatments studied (glaucoma, myasthenia, uretroprostatic disorders),
•Injection site infection,
•Swallowing disorder (to saliva) or absence of spontaneous swallowing reflex not investigated by nasoscopy
•On-going or programmed orthodontic treatment over the study period.
•Untreated dental inflammatory condition (dental caries, gingivitis…)