Informations générales (source: ClinicalTrials.gov)
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. (TOXSIALO)
Interventional
Phase 3
Hospices Civils de Lyon (Voir sur ClinicalTrials)
avril 2022
août 2027
15 avril 2025
Cerebral palsy is the first cause of motor disability in developed countries. It is
associated with altered motor function but also with mental, sensorial and behavior
deficiencies. Drooling frequently occurs in children with cerebral palsy (37 to 58%). It
causes multiple medical and social complications which can all increase disability and
reduce quality of life for the patients and their family. Drooling treatments are various
and includes orofacial rehabilitations, anticholinergic medications, botulinum toxin A
and B salivary gland injections. Surgeries could also be used, but their benefits are
often outweighed by the risk.
- Orofacial rehabilitation is firstly recommended, even if few studies evaluated its
efficacy.
- Medication by Scopoderm®, a cutaneous anticholinergic drug, is frequently used in
spite of frequent side effects and a lack of evidence regarding efficacy.
- Botulinum toxin salivary gland injections (Botox®) were shown to be effective in
reducing the severity of drooling consequences for the patient quality of life up to
12 months after the injections (Reid 2008).
A recent survey carried showed that treatment by Botox® injection would be preferred by
professional to Scopoderm® patch, because of better tolerance and efficacy, even if
Scopoderm® remained more used by professionals (Chaleat-Valayer 2016). However, a
Cochrane review (Walshe 2012) concluded that there is 1) no strong consensus regarding
assessment or the timing of all treatments 2) not enough efficacy studies with high level
of evidence, 3) mostly efficacy studies vs placebo or no intervention 4) a lack of long
term treatment assessment 5) a lack of studies on the patient quality of life.
Our study will be a comparative randomized clinical trial with an active control arm. The
hypothesis is that therapeutic treatment of drooling in children with cerebral palsy
consisting of a standardized rehabilitation treatment associated with a botulinum toxin A
injection (Botox®) in the salivary glands is more effective than the same rehabilitation
treatment associated with a treatment by scopolamine patches (Scopoderm®).
The main outcome will be assessed 15 months after initiation of treatment to evaluate
long-term effectiveness. Patients from both arms of the trial will received
rehabilitation, in order to compare treatment efficacy as it is done in real conditions
of treatment. The efficacy of the treatment will be assessed on the impact of the
drooling perceived by the patients and their family rather than on the measure of
salivary production, as recommended (Walshe 2012).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre médico- infantile - Romagnat - France | Morgane TETARD, MD | Contact (sur clinicalTrials) | |||
| CHU d'Angers - Angers - France | Laurent LACCOURREYE, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APFESEAN Nantes - Nantes - France | Vincent MEDART, MD | Contact (sur clinicalTrials) | |||
| AP-HM - Marseille - France | Christophe BOULAY, MD | Contact (sur clinicalTrials) | |||
| Centre Médico-Chirurgical de Réadaptation des Massues - 69322 - Lyon - France | Emmanuelle CHALEAT-VALAYER | Contact (sur clinicalTrials) | |||
| CHU- Estaing - Clermont-Ferrand - France | Isabelle BARTHELEMY, MD | Contact (sur clinicalTrials) | |||
| CHU-Bordeaux - Bordeaux - France | Brigitte DELEPLANQUE, MD | Contact (sur clinicalTrials) | |||
| CHU-Grenoble - Grenoble - France | Véronique BOURG, MD | Contact (sur clinicalTrials) | |||
| CHU-Nimes - Nîmes - France | Mélanie PORTE, MD | Contact (sur clinicalTrials) | |||
| Hôpital Femme Mère Enfant - HCL - Bron - France | Sonia AYARI, MD | Contact (sur clinicalTrials) | |||
| Hôpitaux de Saint-Maurice - Saint-Maurice - France | Florence MARCHAL, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Aged 4 to 18 years old,
- Cerebral palsy with pathological 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
- Aged 4 to 18 years old,
- Cerebral palsy with pathological 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
- 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, myastenia),
- 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 oro-mandibular dystonia (isolated lingual dystonia accepted)
- Untreated bruxism
- Untreated clinical gastro esophageal reflux
- Untreated dental inflammatory condition (dental caries, gingivitis...)