Comparing Botox injections and Scopolamine patches for drooling in children with cerebral palsy

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.

This study is testing whether Botox injections or Scopolamine patches work better to reduce drooling in children with cerebral palsy aged 4 to 18.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 4 Years to 18 Years
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 11 sites (Angers and 10 other locations)
• Trial ID: NCT03616067 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Botox injections versus Scopolamine patches in treating drooling in children aged 4 to 18 with cerebral palsy. Drooling is a common issue in these children, significantly impacting their quality of life. The study aims to determine which treatment provides better relief from drooling symptoms, using a randomized approach to compare the two interventions. Participants will be monitored for changes in drooling severity and any side effects associated with the treatments.

Who should consider this trial

Good fit: Ideal candidates are children aged 4 to 18 with cerebral palsy who experience significant drooling that affects their daily life.

Not a fit: Patients who have had previous surgeries for drooling or have contraindications to the treatments being studied may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for managing drooling in children with cerebral palsy, improving their quality of life.

How similar studies have performed: Previous studies have shown that botulinum toxin injections can be effective for drooling, suggesting potential success for this comparative approach.

Eligibility criteria

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

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, 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...)

Where this trial is running

Angers and 10 other locations

• CHU d'Angers — Angers, France (RECRUITING)
• CHU-Bordeaux — Bordeaux, France (RECRUITING)
• Hôpital Femme Mère Enfant - HCL — Bron, France (RECRUITING)
• CHU- Estaing — Clermont-Ferrand, France (RECRUITING)
• CHU-Grenoble — Grenoble, France (RECRUITING)
• Centre Médico-Chirurgical de Réadaptation des Massues — Lyon, France (RECRUITING)
• AP-HM — Marseille, France (RECRUITING)
• APFESEAN Nantes — Nantes, France (RECRUITING)
• CHU-Nimes — Nîmes, France (RECRUITING)
• Centre médico- infantile — Romagnat, France (RECRUITING)
• Hôpitaux de Saint-Maurice — Saint-Maurice, France (RECRUITING)

Study contacts

• Principal investigator: Sandrine TOUZET, MD — Hospices Civils de Lyon
• Study coordinator: Karine POYAU, PhD

Conditions: Cerebral Palsy