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

January 28, 2026 updated by: Hospices Civils de Lyon

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.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
      • Bordeaux, France
        • CHU-Bordeaux
      • Bron, France
        • Hôpital Femme Mère Enfant - HCL
      • Clermont-Ferrand, France
        • CHU- Estaing
      • Grenoble, France
        • CHU-Grenoble
      • Lyon, France, 69322
        • Centre Médico-Chirurgical de Réadaptation des Massues
      • Marseille, France
        • AP-HM
      • Nantes, France
        • APFESEAN Nantes
      • Nîmes, France
        • CHU-Nimes
      • Romagnat, France
        • Centre médico- infantile
      • Saint-Maurice, France
        • Hôpitaux de Saint-Maurice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox® injection arm
Botox® injection in salivary glands will be performed one month after inclusion. It will be performed with one injection point per gland (parotids and submandibulars).
Drug: Botox® injection
Botox® injection in salivary glands will be performed one month after inclusion. It will be performed with one injection point per gland (parotids and submandibulars)
Active Comparator: Scopoderm® patches arm
Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear
Drug: Scopoderm® patches arm
Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drooling Impact Scale (DIS scale)
Time Frame: after 15 months of treatment
The DIS scale is a questionnaire of 10 questions with a score of 100 points which will be completed by the patient's entourage (family and/or caregivers). This scale has a good validity and sensitivity to changes in the context of the evaluation of the drooling in children with CP, with a score difference of 10 points considered as clinical significant.
after 15 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIS scale
Time Frame: at 1, 3, 6, 9 and 12 months of treatment
The DIS scale is a questionnaire of 10 questions with a score of 100 points which will be completed by the patient's entourage (family and/or caregivers). This scale has a good validity and sensitivity to changes in the context of the evaluation of the drooling in children with CP, with a score difference of 10 points considered as clinical significant
at 1, 3, 6, 9 and 12 months of treatment
Drooling severity
Time Frame: at 1, 3, 6, 9, 12 and 15 months of treatment
average number of bibs used per day per patient
at 1, 3, 6, 9, 12 and 15 months of treatment
Clinical complications of the drooling
Time Frame: at 1, 3, 6, 9, 12 and 15 months of treatment
The number of hospitalizations for pulmonary infections and the average number of prescriptions for antibiotic treatment linked to bronchial secondary infection.
at 1, 3, 6, 9, 12 and 15 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandrine TOUZET, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

September 22, 2025

Study Completion (Actual)

September 22, 2025

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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