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Botox vs. patch: which stops drooling better in kids with cerebral palsy?

NCT ID NCT03616067

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two treatments for drooling in children with cerebral palsy: Botox injections into the salivary glands and scopolamine skin patches. Both groups also received rehabilitation therapy. The goal was to see which treatment reduced drooling more over 15 months. The trial was terminated early after enrolling only 23 children, so the results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin A (Botox) injection and scopolamine (Scopoderm) patches
What this could lead to
If it works, this could point toward a more effective, longer-lasting treatment for drooling in children with cerebral palsy, improving quality of life.
What could go wrong
The trial was terminated early with only 23 participants, so results are limited. Both treatments have side effects, and the study may not provide clear answers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

23 people

The number who actually took part.

Started

Apr 2022

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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…)

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Conditions

The condition(s) this trial relates to.

cerebral palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral palsy

Contacts and locations

Locations

  • AP-HM

    Marseille, France

  • APFESEAN Nantes

    Nantes, France

  • CHU d'Angers

    Angers, France

  • CHU- Estaing

    Clermont-Ferrand, France

  • CHU-Bordeaux

    Bordeaux, France

  • CHU-Grenoble

    Grenoble, France

  • CHU-Nimes

    Nîmes, France

  • Centre Médico-Chirurgical de Réadaptation des Massues

    Lyon, 69322, France

  • Centre médico- infantile

    Romagnat, France

  • Hôpital Femme Mère Enfant - HCL

    Bron, France

  • Hôpitaux de Saint-Maurice

    Saint-Maurice, France

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