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

NCT03616067 | Terminated Phase 3 DMC

• 1 other identifier: 69HCL18_0235
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 11

Brief 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%). 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).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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.

  after 15 months of treatment

Secondary Outcomes (3)

• DIS scale

  at 1, 3, 6, 9 and 12 months of treatment

• Drooling severity

  at 1, 3, 6, 9, 12 and 15 months of treatment

• Clinical complications of the drooling

  at 1, 3, 6, 9, 12 and 15 months of treatment

Study Arms (2)

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).

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

Drug: Scopoderm® patches arm

Interventions

Botox® injection DRUG

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)

Botox® injection arm

Scopoderm® patches arm DRUG

Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear.

Scopoderm® patches arm

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous history of surgery for drooling,
• 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…)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (11)

CHU d'Angers

Angers, France

Location

CHU-Bordeaux

Bordeaux, France

Location

Hôpital Femme Mère Enfant - HCL

Bron, France

Location

CHU- Estaing

Clermont-Ferrand, France

Location

CHU-Grenoble

Grenoble, France

Location

Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, 69322, France

Location

AP-HM

Marseille, France

Location

APFESEAN Nantes

Nantes, France

Location

CHU-Nimes

Nîmes, France

Location

Centre médico- infantile

Romagnat, France

Location

Hôpitaux de Saint-Maurice

Saint-Maurice, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Sandrine TOUZET, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: April 27, 2022
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)