Cerebral PalsyPhase 3TOXSIALONCT03616067
Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy
A Phase 3 study testing Botox® injection and Scopoderm® patches arm in people with Cerebral Palsy, run by Hospices Civils de Lyon at 11 sites in France.
Trial summary
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%). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Botox® injection and Scopoderm® patches arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 11 sitesFrance
- Study dates
- 27 Apr 2022to 22 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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…)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU d'Angers
Angers
CHU-Bordeaux
Bordeaux
Hôpital Femme Mère Enfant - HCL
Bron
CHU- Estaing
Clermont-Ferrand
CHU-Grenoble
Grenoble
Centre Médico-Chirurgical de Réadaptation des Massues
Lyon, 69322
AP-HM
Marseille
APFESEAN Nantes
Nantes
CHU-Nimes
Nîmes
Centre médico- infantile
Romagnat
Hôpitaux de Saint-Maurice
Saint-Maurice
About this study
Official title: 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).
Read more
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).
- Conditions
- Cerebral Palsy
- Being tested
- Botox® injection, Scopoderm® patches arm
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox® injectionDrug
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)
Scopoderm® patches armDrug
Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear.
| Study group | Role | What they receive |
|---|---|---|
| Botox® injection arm | Experimental | 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). Receives: Drug: Botox® injection |
| Scopoderm® patches arm | Active comparator | Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear Receives: Drug: Scopoderm® patches arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drooling Impact Scale (DIS scale)
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.
Measured: after 15 months of treatment
Secondary outcomes (3)
DIS scale
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
Measured: at 1, 3, 6, 9 and 12 months of treatment
Drooling severity
average number of bibs used per day per patient
Measured: at 1, 3, 6, 9, 12 and 15 months of treatment
Clinical complications of the drooling
The number of hospitalizations for pulmonary infections and the average number of prescriptions for antibiotic treatment linked to bronchial secondary infection.
Measured: at 1, 3, 6, 9, 12 and 15 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start27 Apr 2022
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Why it stopped: The Steering Committee decided on 22/09/2025 to end the project, due to persistent issues: enrolment suspended because of supply shortages and the arrival of alternative treatments, as well as the end of a key supply agreement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine TOUZET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616067
- Sponsor's protocol ID
- 69HCL18_0235
- Acronym
- TOXSIALO
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2018
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03616067
- Acronym / sponsor ID
- TOXSIALO / 69HCL18_0235
- Conditions
- Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Steering Committee decided on 22/09/2025 to end the project, due to persistent issues: enrolment suspended because of supply shortages and the arrival of alternative treatments, as well as the end of a key supply agreement.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox® injection arm | Experimental | Drug: Botox® injectionBotox® injection in salivary glands will be performed one month after inclusion. It will be performed with one injection point per gland (parotids and submandibulars). |
| Scopoderm® patches arm | Active comparator | Drug: Scopoderm® patches armScopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox® injectionBotox® 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 arm |
| Scopoderm® patches armScopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear. | Drug | Scopoderm® patches arm |
Primary outcome
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.
3 secondary outcomes
DIS scale
Time frame: 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
Clinical complications of the drooling
Time frame: at 1, 3, 6, 9, 12 and 15 months of treatment
Results and safety
The study was stopped early (reason given: The Steering Committee decided on 22/09/2025 to end the project, due to persistent issues: enrolment suspended because of supply shortages and the arrival of alternative treatments, as well as the end of a key supply agreement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine TOUZET, MD principal investigator
Hospices Civils de Lyon
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botox® injection and Scopoderm® patches arm in people with Cerebral Palsy, run by Hospices Civils de Lyon at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Steering Committee decided on 22/09/2025 to end the project, due to persistent issues: enrolment suspended because of supply shortages and the arrival of alternative treatments, as well as the end of a key supply agreement.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drooling Impact Scale (DIS scale) (time frame: after 15 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.