Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 9:41 PM
Study NCT ID:
NCT03616067
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drooling Impact Scale (DIS scale)', 'timeFrame': 'after 15 months of treatment', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'DIS scale', 'timeFrame': 'at 1, 3, 6, 9 and 12 months of treatment', 'description': "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"}, {'measure': 'Drooling severity', 'timeFrame': 'at 1, 3, 6, 9, 12 and 15 months of treatment', 'description': 'average number of bibs used per day per patient'}, {'measure': 'Clinical complications of the drooling', 'timeFrame': 'at 1, 3, 6, 9, 12 and 15 months of treatment', 'description': 'The number of hospitalizations for pulmonary infections and the average number of prescriptions for antibiotic treatment linked to bronchial secondary infection.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': '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.\n\n* Orofacial rehabilitation is firstly recommended, even if few studies evaluated its efficacy.\n* Medication by Scopoderm®, a cutaneous anticholinergic drug, is frequently used in spite of frequent side effects and a lack of evidence regarding efficacy.\n* 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).\n\nA 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.\n\nOur 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®).\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 4 to 18 years old,\n* Cerebral palsy with pathological drooling,\n* Significant impact of drooling on the children (DIS score ≥40),\n* Affiliated or beneficiary of a social security scheme,\n* At least one of the parents understanding and speaking French,\n* Written consent form signed by both parents\n\nExclusion Criteria:\n\n* Previous history of surgery for drooling,\n* Injection of botulinum toxin (all locations) in the 3 months prior to the inclusion,\n* Treatment by scopolamine patch (Scopoderm®) or other anticholinergic (Artane®, etc.) in the month prior to inclusion,\n* Contraindication to the anesthetic or sedation,\n* Contraindication to one of the treatments studied (glaucoma, myastenia),\n* Swallowing disorder (to saliva) or absence of spontaneous swallowing reflex not investigated by nasoscopy\n* On-going or programmed orthodontic treatment over the study period.\n* Untreated oro-mandibular dystonia (isolated lingual dystonia accepted)\n* Untreated bruxism\n* Untreated clinical gastro esophageal reflux\n* Untreated dental inflammatory condition (dental caries, gingivitis…)'}, 'identificationModule': {'nctId': 'NCT03616067', 'acronym': 'TOXSIALO', 'briefTitle': 'Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '69HCL18_0235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botox® injection arm', 'description': '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).', 'interventionNames': ['Drug: Botox® injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scopoderm® patches arm', 'description': 'Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear', 'interventionNames': ['Drug: Scopoderm® patches arm']}], 'interventions': [{'name': 'Botox® injection', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Botox® injection arm']}, {'name': 'Scopoderm® patches arm', 'type': 'DRUG', 'description': 'Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear.', 'armGroupLabels': ['Scopoderm® patches arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent LACCOURREYE, MD', 'role': 'CONTACT', 'email': 'lalaccourreye@chu-angers.fr'}, {'name': 'Laurent LACCOURREYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brigitte DELEPLANQUE, MD', 'role': 'CONTACT', 'email': 'brigitte.deleplanque@chu-bordeaux.fr'}, {'name': 'Brigitte DELEPLANQUE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU-Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sonia AYARI, MD', 'role': 'CONTACT', 'email': 'sonia.ayari-khalfallah@chu-lyon.fr'}, {'name': 'Sonia AYARI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Femme Mère Enfant - HCL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle BARTHELEMY, MD', 'role': 'CONTACT', 'email': 'ibarthelemy@chu-clermontferrand.fr'}, {'name': 'Isabelle BARTHELEMY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU- Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Véronique BOURG, MD', 'role': 'CONTACT', 'email': 'vbourg@chu-grenoble.fr'}, {'name': 'Véronique BOURG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU-Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69322', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle CHALEAT-VALAYER', 'role': 'CONTACT', 'email': 'chaleat-valayer.e@cmcr-massues.com'}], 'facility': 'Centre Médico-Chirurgical de Réadaptation des Massues', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe BOULAY, MD', 'role': 'CONTACT', 'email': 'Christophe.BOULAY@ap-hm.fr'}, {'name': 'Christophe BOULAY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent MEDART, MD', 'role': 'CONTACT', 'email': 'vinc.20100@gmail.com'}, {'name': 'Vincent MEDART, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APFESEAN Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mélanie PORTE, MD', 'role': 'CONTACT', 'email': 'melanie.porte@chu-nimes.fr'}, {'name': 'Mélanie PORTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU-Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Romagnat', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Morgane TETARD, MD', 'role': 'CONTACT', 'email': 'm.tetard@centremedicalinfantile.com'}, {'name': 'Morgane TETARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre médico- infantile', 'geoPoint': {'lat': 45.72955, 'lon': 3.10061}}, {'city': 'Saint-Maurice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence MARCHAL, MD', 'role': 'CONTACT', 'email': 'Florence.MARCHAL@ght94n.fr'}, {'name': 'Florence MARCHAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpitaux de Saint-Maurice', 'geoPoint': {'lat': 48.82182, 'lon': 2.42716}}], 'centralContacts': [{'name': 'Karine POYAU, PhD', 'role': 'CONTACT', 'email': 'karine.poyau@chu-lyon.fr', 'phone': '33 472 11 53 81'}, {'name': 'Emmanuelle CHALEAT-VALAYER, MD', 'role': 'CONTACT', 'email': 'chaleat-valayer.e@cmcr-massues.com', 'phone': '33 472 38 48 23'}], 'overallOfficials': [{'name': 'Sandrine TOUZET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}