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Study identifier: NCT03616067 Synced from ClinicalTrials.gov · August 04, 2026
● Terminated

Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy

Condition: Cerebral Palsy  ·  Sponsor: Hospices Civils de Lyon

PhasePhase 3
Planned participants23
Who can joinAll sexes, 4 Years to 18 Years
Healthy volunteersNo

About this study

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 enoug…

This description comes directly from the study's public registry record.

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Locations (11)

CHU d'AngersAngers, France
CHU-BordeauxBordeaux, France
Hôpital Femme Mère Enfant - HCLBron, France
CHU- EstaingClermont-Ferrand, France
CHU-GrenobleGrenoble, France
Centre Médico-Chirurgical de Réadaptation des MassuesLyon, France
AP-HMMarseille, France
APFESEAN NantesNantes, France
CHU-NimesNîmes, France
Centre médico- infantileRomagnat, France
Hôpitaux de Saint-MauriceSaint-Maurice, France

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