Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT03380559
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ratio 1:1:1'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of pain intensity between injection of treatment and 6 months after injection', 'timeFrame': 'At the moment of injection', 'description': 'Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS).'}, {'measure': 'Variation of pain intensity between injection of treatment and 6 months after injection', 'timeFrame': '6 months after injection', 'description': 'Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS.'}], 'secondaryOutcomes': [{'measure': 'Spontaneous pain intensity at rest', 'timeFrame': 'Before injection, 3 months after injection and 6 months after injection', 'description': 'Evaluate pain intensity at rest with the VAS.'}, {'measure': 'Pain intensity of motion of wrist flexion', 'timeFrame': 'Before injection, 3 months after injection and 6 months after injection', 'description': 'Evaluate pain intensity of motion of wrist flexion with the VAS.'}, {'measure': 'Pain intensity at proximal insertion palpation on epicondylitis muscle', 'timeFrame': 'Before injection, 3 months after injection and 6 months after injection', 'description': 'Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.'}, {'measure': 'Number of days of sick leave', 'timeFrame': '6 months after injection', 'description': 'Number of days of sick leave will be noted and collected'}, {'measure': 'The percentage of patients returning to professional activity or sportive activity', 'timeFrame': '6 months after injection'}, {'measure': 'Measurement of prehensile grasp capabilities by a force', 'timeFrame': 'At baseline, 3 months after injection, 6 months after injection', 'description': 'The force will be measured by Jamar Hydraulic hand dynamometer.'}, {'measure': 'Functional outcome after injection', 'timeFrame': 'At baseline, 3 months after injection, 6 months after injection', 'description': 'Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation'}, {'measure': 'Anxiety and depression tests', 'timeFrame': 'At baseline, 3 months after injection, 6 months after injection', 'description': 'Hospital Anxiety and Depression scale will be used'}, {'measure': 'Frequence and gravity of adverse events', 'timeFrame': 'At baseline, 3 months after injection, 6 months after injection', 'description': 'Adverse events will be collected and their severity will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epicondylitis', 'Botulinum toxin', 'Corticoid'], 'conditions': ['Epicondylitis']}, 'descriptionModule': {'briefSummary': "The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.\n\nAs secondary objectives, the study aims to\n\n* demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.\n* evaluate tolerance of treatment by grip strength measurement and adverse event collection.", 'detailedDescription': 'This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.\n\nAll patients will be randomized in 3 following parallel treatment groups:\n\nGroup A : botulinum toxin + corticoid\n\nGroup C : placebo of toxin + corticoid\n\nGroup T : botulinum toxin + placebo corticoid\n\nThe study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged between 18 and 60 years;\n* Physical disability or not;\n* Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;\n* Signed consent obtained;\n* Covered by health insurance.\n\nExclusion Criteria:\n\n* Central nervous system disorders result in spasticity in epicondylitis limb;\n* History of severe psychiatric disorder;\n* History of myasthenia gravis;\n* Pregnant or breastfeeding woman;\n* Unable to understand or respond to questions;\n* Contraindication to botulinum toxin or corticoid;\n* Treatment with botulinum toxin 3 months prior to baseline;\n* Anticoagulant theraphy;\n* Difficult to follow-up in the study;\n* Patient under guardianship, or deprived of liberty by a judicial order.'}, 'identificationModule': {'nctId': 'NCT03380559', 'acronym': 'EPITOX', 'briefTitle': 'A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis', 'orgStudyIdInfo': {'id': 'P160926J'}, 'secondaryIdInfos': [{'id': '2017-001709-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A : Association (botulinum toxin + corticoid)', 'interventionNames': ['Drug: Injection, botulinum toxin + corticoid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C : placebo of toxin + corticoid :', 'interventionNames': ['Drug: Injection, placebo of toxin + corticoid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group T : botulinum toxin + placebo corticoid', 'interventionNames': ['Drug: Injection, botulinum toxin + placebo corticoid']}], 'interventions': [{'name': 'Injection, botulinum toxin + corticoid', 'type': 'DRUG', 'description': '* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control\n* Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)', 'armGroupLabels': ['Group A : Association (botulinum toxin + corticoid)']}, {'name': 'Injection, placebo of toxin + corticoid', 'type': 'DRUG', 'description': '* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control\n* Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)', 'armGroupLabels': ['Group C : placebo of toxin + corticoid :']}, {'name': 'Injection, botulinum toxin + placebo corticoid', 'type': 'DRUG', 'description': '* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control\n* Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)', 'armGroupLabels': ['Group T : botulinum toxin + placebo corticoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Hauts-de-Seine', 'country': 'France', 'facility': 'Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'François Genêt, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}