Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT04152434
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in monthly migraine days', 'timeFrame': '5 months', 'description': 'Change in frequency of monthly migraine days'}], 'secondaryOutcomes': [{'measure': 'Change in frequency of monthly migraine days adding Erenumab to another preventive treatment,', 'timeFrame': '5 months', 'description': 'Change in the frequency of monthly migraine days with Botox plus Erenumab,'}, {'measure': 'Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment', 'timeFrame': '5 months', 'description': 'Change in the freqyency of monthly migraine days with an oral preventive plu erenumab'}, {'measure': 'change in frequency of monthly migraine days with Erenumab alone', 'timeFrame': '5 months', 'description': 'change in frequency of monthly migraine days without adding another preventive to Erenumab'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Chronic Migraine']}, 'descriptionModule': {'briefSummary': 'Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy', 'detailedDescription': 'The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.\n\nMigraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with more than 15 migraine days per month, receiving Botox, or an oral preventive treatment, or without any preventive therapy. Have failed more than 3 preventive treatments previously', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic migraineurs with failure to more than 3 preventive treatments\n* Naive to anti CGRP monclonal antibodies\n\nExclusion Criteria:\n\n* episodic migraineurs,\n* Other headache types'}, 'identificationModule': {'nctId': 'NCT04152434', 'briefTitle': 'Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Clinique des Céphalées de Montréal'}, 'officialTitle': 'Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy; a Real World Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Erenumab 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reduction in monthly migraine days all cohorts at 4 months', 'description': 'Migraineurs with 15-30 headache days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly headache days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)', 'interventionNames': ['Drug: Erenumab Auto-Injector']}, {'label': 'Selection of elegible paitients', 'description': 'A total of 158 patients were involved in this study. 118 patients (75%), received Erenumab 140 mg., and 40 patients (25%) received 70 mg. In the Botox cohort, of 650 patients, 90 (13%) patients were eligible. In the no Botox cohort, 533 patients, 83 (15%) patients were eligible.', 'interventionNames': ['Drug: Erenumab Auto-Injector']}, {'label': 'Rate of adverse events related to Erenumab', 'description': '72 adverse events were experienced during the 4 months of treatment, mostly with the 140 mg. dose. The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1%', 'interventionNames': ['Drug: Erenumab Auto-Injector']}], 'interventions': [{'name': 'Erenumab Auto-Injector', 'type': 'DRUG', 'otherNames': ['Botox, and oral migraine preventives'], 'description': 'Assess synergy of add on medication to Erenumab', 'armGroupLabels': ['Rate of adverse events related to Erenumab', 'Reduction in monthly migraine days all cohorts at 4 months', 'Selection of elegible paitients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1V1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Guy Pierre Boudreau', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Guy P Boudreau, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique des Céphalées de Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique des Céphalées de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, fellow in headache medecine', 'investigatorFullName': 'Guy Pierre Boudreau md', 'investigatorAffiliation': 'Clinique des Céphalées de Montréal'}}}}