Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
Study NCT ID:
NCT02101892
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2014-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000639', 'term': 'Amitriptyline'}], 'ancestors': [{'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-01', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-30', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predictive value of the pre-treatment pain measures parameter(s) for benefit from amitriptyline treatment', 'timeFrame': 'one year', 'description': 'ANCOVA will be utilized, based on factors treatment (amitriptyline or placebo), conditioned pain modulation capabilities (responder or non-responder), their interaction, a number of covariates, to predict reduction attacks.'}], 'secondaryOutcomes': [{'measure': 'predictive value of pain-related psychological parameters for benefit from amitriptyline treatment', 'timeFrame': 'one year', 'description': "The scores for Spielberger's anxiety state and trait questionnaire, and for pain catastrophising questionnaire will be used."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine', 'Amitriptyline', 'pain modulation', 'pain psychophysics', 'pain neurophysiology', 'preventive treatment'], 'conditions': ['Migraine', 'Preventive Treatment']}, 'descriptionModule': {'briefSummary': "A major reason for the substantial underuse of pharmacological prevention of migraine is its inadequate efficacy, since only \\~50% of patients respond to a specific agent. There is currently no evidence-based way to identify the patients that will respond to a specific preventive treatment. Amitriptyline is one of the commonest agents used for migraine prevention, strengthening patient's pain inhibitory capacity. Individual tailoring of analgesics according to pain inhibitory capacity has been shown effective by our group for painful diabetic neuropathy patients. Specifically, patients with reduced pain inhibition capacity gained more from a drug that augment pain inhibition as compared to those with efficient inhibitory capacity. The investigators now propose to assess migraineurs for their pain inhibition capacity, and examine whether, along similar reasoning, those with reduced inhibitory capacity are the ones more likely to respond to amitriptyline. Psychophysical and neurophysiological dimensions of pain inhibitory modulation will be assessed in migraineurs, who will, subsequently, receive either amitriptyline or placebo for 8 weeks, in a randomized two arms parallel double blind design, and followed up for attacks reduction. The investigators expect to identify the best predictors for efficacy of migraine prevention by the study drug. This approach will promote individualization of migraine therapy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18\n* premenopausal\n* meeting the international headache society criteria for migraine\n* having \\>4 attacks or days of migraine/month\n\nExclusion Criteria:\n\n* baseline month diary indicating lower frequency of migraine\n* chronic migraine (\\>15 days of headache per month)\n* use of migraine preventive treatment during previous 3 month\n* language barrier or cognitive dysfunction'}, 'identificationModule': {'nctId': 'NCT02101892', 'briefTitle': "Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation", 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': "Prediction of Migraine Prevention Efficacy: Individualization of Treatment by Coupling Drug's Mode of Action With Patient's Mechanism of Pain Modulation", 'orgStudyIdInfo': {'id': '0102-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amitriptyline', 'description': 'Amitriptyline, 25 mg per os, daily, evening, for 8 weeks; starting dose is 12.5 mg for 2 days', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'sugar pills', 'interventionNames': ['Drug: Amitriptyline']}], 'interventions': [{'name': 'Amitriptyline', 'type': 'DRUG', 'otherNames': ['Elatrol'], 'description': 'per os, daily, evening', 'armGroupLabels': ['placebo']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['sugar pills'], 'description': 'per os, daily, evening', 'armGroupLabels': ['Amitriptyline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'David Yarnitsky, MD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus and Technion Medical School'}, {'name': 'Yelena Granovsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus and Technion Medical School'}, {'name': 'Michal Granot, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nursing School, University of Haifa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Migraine Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}