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 drooling
- Registration Number
- 2024-512160-58-00
- Lead Sponsor
- Hospices Civils De Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- 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 Change in score of the degree and impact of the drooling between baseline and after 15 months of treatment, measured by the DIS scale Change in score of the degree and impact of the drooling between baseline and after 15 months of treatment, measured by the DIS scale
- Secondary Outcome Measures
Name Time Method Description of the nature of the adverse events that have occurred (by symptom), as well as their frequency and their intensity, measured using the AE intensity scale (see § 8.1.5 safety) at each time point. Description of the nature of the adverse events that have occurred (by symptom), as well as their frequency and their intensity, measured using the AE intensity scale (see § 8.1.5 safety) at each time point.
Scores of the degree and impact of the drooling, measured by the DIS scale at 1, 3, 6, 9 and 12 months of treatment (compared to the baseline measurement at the initiation of treatment at M0). Scores of the degree and impact of the drooling, measured by the DIS scale at 1, 3, 6, 9 and 12 months of treatment (compared to the baseline measurement at the initiation of treatment at M0).
Severity of the drooling (quantity of saliva), measured by the average number of bibs used per day per patient (counted over 7 days) at 1, 3, 6, 9, 12 and 15 months (compared to the baseline measurement at treatment initiation at M0). Severity of the drooling (quantity of saliva), measured by the average number of bibs used per day per patient (counted over 7 days) at 1, 3, 6, 9, 12 and 15 months (compared to the baseline measurement at treatment initiation at M0).
Clinical complications of the drooling, measured by the number of hospitalizations for pulmonary infections and the number of prescriptions for antibiotic treatment linked to bronchial secondary infection at 1, 3, 6, 9, 12 and 15 months. Clinical complications of the drooling, measured by the number of hospitalizations for pulmonary infections and the number of prescriptions for antibiotic treatment linked to bronchial secondary infection at 1, 3, 6, 9, 12 and 15 months.
Quantification of the adverse events, measured by the proportion of patients with at least one adverse event and the number of adverse events per patient at each time point. Quantification of the adverse events, measured by the proportion of patients with at least one adverse event and the number of adverse events per patient at each time point.
Level of treatment discontinuation due to adverse events, measured by the proportion of patients with at least one adverse event having led to a discontinuation of the treatment at each time point. Level of treatment discontinuation due to adverse events, measured by the proportion of patients with at least one adverse event having led to a discontinuation of the treatment at each time point.
Description of the nature and the frequency of the rehabilitation procedures used over 15 months. Description of the nature and the frequency of the rehabilitation procedures used over 15 months.
Description of the experimented strategies used (dose modifications /reinjections and their justifications) at each time point. Description of the experimented strategies used (dose modifications /reinjections and their justifications) at each time point.
Description of concomitant treatments used at each time point. Description of concomitant treatments used at each time point.
Trial Locations
- Locations (12)
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
🇫🇷Aix En Provence, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷Bordeaux, France
HOPITAUX DE SAINT MAURICE
🇫🇷SAINT-MAURICE, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷La Tronche, France
ESEAN Nantes
🇫🇷France
Centre Hospitalier Universitaire De Nimes
🇫🇷Nimes Cedex 9, France
Centre Médico-Chirurgical Réadaptation des Massues - Croix-Rouge française
🇫🇷Lyon, France
Hospices Civils De Lyon
🇫🇷Bron, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷Saint-Etienne, France
Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Scroll for more (2 remaining)Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis🇫🇷Aix En Provence, FrancePascal GRANIERSite contact0679661399pgranier@ch-aix.fr