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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)

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ClinicalTrials.gov Identifier: NCT03616067
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Botox® injection Drug: Scopoderm® patches arm Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Drooling severity [ Time Frame: at 1, 3, 6, 9, 12 and 15 months of treatment ]
    average number of bibs used per day per patient

  3. 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.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616067


Contacts
Contact: Karine POYAU, PhD 33 472 11 53 81 karine.poyau@chu-lyon.fr
Contact: Emmanuelle CHALEAT-VALAYER, MD 33 472 38 48 23 chaleat-valayer.e@cmcr-massues.com

Locations
France
Centre Médico-Chirurgical de Réadaptation des Massues Not yet recruiting
Lyon, France, 69322
Contact: Emmanuelle CHALEAT-VALAYER       chaleat-valayer.e@cmcr-massues.com   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sandrine TOUZET, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03616067     History of Changes
Other Study ID Numbers: 69HCL18_0235
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Sialorrhea
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Cholinergic Antagonists
Muscarinic Antagonists
Parasympatholytics