Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-29 @ 4:27 AM
Study NCT ID:
NCT00904150
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2009-05-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Molecular Genetics of Menstrual Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'e.macgregor@qmul.ac.uk', 'phone': '+44 7774 868628', 'title': 'Professor Anne MacGregor', 'organization': 'Centre for Neuroscience and Trauma, Queen Mary, University of London'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'This is not an interventional study so serious and another \\[non-serious\\] adverse events could not be assessed.', 'eventGroups': [{'id': 'EG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'No PROGINS insert', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Heterozygote', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Homozygote', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.513', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'PR PROGINS', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all samples were suitable for analysis for each outcome measure'}, {'type': 'PRIMARY', 'title': 'Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'Genotype GG', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Genotype GA', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Genotype AA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'ESR1 G594A', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all samples were suitable for analysis for each outcome measure'}, {'type': 'SECONDARY', 'title': 'Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'Genotype GG', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Genotype GA', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Genotype AA', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.434', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.75', 'groupDescription': 'Analysis of distribution of TNF genotype frequencies between groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'TNF', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all samples were suitable for analysis for each outcome measure'}, {'type': 'SECONDARY', 'title': 'SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'Genotype TT', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Genotype TG', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Genotype GG', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.95', 'groupDescription': 'Analysis of distribution of SYNE1 genotype frequencies between groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'SYNE1', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all samples were suitable for analysis for each outcome measure'}, {'type': 'PRIMARY', 'title': 'Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'Genotype CC', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Genotype CG', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Genotype GG', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 years', 'description': 'ESR1 C325G', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all samples were suitable for analysis for each outcome measure'}, {'type': 'PRIMARY', 'title': 'Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'ESR expression in follicular phase', 'categories': [{'measurements': [{'value': '15.98', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG000'}, {'value': '16.73', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG001'}]}]}, {'title': 'ESR expression in luteal phase', 'categories': [{'measurements': [{'value': '16.58', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG000'}, {'value': '15.62', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG001'}]}]}, {'title': 'PGR expression in follicular phase', 'categories': [{'measurements': [{'value': '9.62', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG000'}, {'value': '9.80', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG001'}]}]}, {'title': 'PGR expression in luteal phase', 'categories': [{'measurements': [{'value': '8.95', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG000'}, {'value': '8.69', 'spread': 'NA', 'comment': 'Data not reported', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 years', 'description': 'PgR and ESR', 'unitOfMeasure': 'number of genes expressed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure'}, {'type': 'SECONDARY', 'title': 'Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'OG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'classes': [{'title': 'TNF expression in follicular phase', 'categories': [{'measurements': [{'value': '17.16', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG000'}, {'value': '17.33', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG001'}]}]}, {'title': 'TNF expression in luteal phase', 'categories': [{'measurements': [{'value': '16.24', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG000'}, {'value': '16.96', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG001'}]}]}, {'title': 'SYNE1 expression in follicular phase', 'categories': [{'measurements': [{'value': '21.56', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG000'}, {'value': '20.68', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG001'}]}]}, {'title': 'SYNE1 expression in luteal phase', 'categories': [{'measurements': [{'value': '20.01', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG000'}, {'value': '20.06', 'spread': 'NA', 'comment': 'Not reported', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 years', 'description': 'TNF and SYNE1', 'unitOfMeasure': 'number of genes expressed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'FG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}], 'periods': [{'title': 'Saliva Samples (DNA)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '145'}]}], 'dropWithdraws': [{'type': 'saliva samples not suitable for assay', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Australian samples of different genotype', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '145'}]}]}, {'title': 'Blood Samples (RNA): Follicular Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Blood Samples (RNA): Luteal Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 Menstrual Migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'id': 'BG001', 'title': '2 No Migraine', 'description': 'Caucasian women with no personal history of migraine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '585', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2009-05-17', 'resultsFirstSubmitDate': '2013-09-08', 'studyFirstSubmitQcDate': '2009-05-18', 'lastUpdatePostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-18', 'studyFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'PR PROGINS'}, {'measure': 'Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'ESR1 G594A'}, {'measure': 'Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'ESR1 C325G'}, {'measure': 'Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'PgR and ESR'}], 'secondaryOutcomes': [{'measure': 'Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'TNF'}, {'measure': 'SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'SYNE1'}, {'measure': 'Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine', 'timeFrame': '6 years', 'description': 'TNF and SYNE1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menstruation', 'migraine', 'menstrual migraine', 'genetics'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that genes that play a role in menstrual migraine can be identified using a well characterised migraine population and a comprehensive genome-wide association scan approach.\n\nThe aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.\n\nIn this case control study, saliva samples will be taken from 300 cases and 300 controls for DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Caucasian women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll cases and controls must:\n\n* Be over 18 years\n* Caucasian\n* Provide written, informed consent\n* Clearly understand and be able to comply with all the trial procedures, as required\n* Not have taken part in trials of any investigational products within the previous 4 weeks\n\nDNA Study:\n\n* Cases must have at least a 12-month current or past history of menstrual migraine\n\nRNA Study:\n\n* Cases must have at least a 12-month current history of menstrual migraine\n* Cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis\n* Controls must still be having menstrual periods\n\nExclusion Criteria:\n\nDNA Study:\n\n* Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection\n\nRNA Study:\n\n* Cases and controls will not be eligible for participation if they have:\n\n * Polycystic ovarian syndrome;\n * Taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones);\n * Donated or lost a significant amount of blood (\\> 550 mL) within the previous 12 weeks\n * Additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine'}, 'identificationModule': {'nctId': 'NCT00904150', 'briefTitle': 'Study of the Molecular Genetics of Menstrual Migraine', 'organization': {'class': 'OTHER', 'fullName': 'The City of London Migraine Clinic'}, 'officialTitle': 'A Case-control Study of the Molecular Genetics of Menstrual Migraine (Pure Menstrual and Menstrually-related Migraine)', 'orgStudyIdInfo': {'id': 'COLMC-GEN-2007'}, 'secondaryIdInfos': [{'id': 'REC Ref: 07/H0703/107'}, {'id': 'Proposal # 36470'}, {'id': 'Grant Application 2007/03'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1 Menstrual migraine', 'description': 'Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic'}, {'label': '2 No migraine', 'description': 'Caucasian women with no personal history of migraine'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1M 6DX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The City of London Migraine Clinic', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'E A MacGregor, FFSRH MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Neuroscience and Trauma, Queen Mary, University of London'}, {'name': 'Lyn Griffiths, BSc(Hons) PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Genomics Research Centre Griffith University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The City of London Migraine Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Griffith University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor E Anne MacGregor', 'investigatorFullName': 'Dr E Anne MacGregor', 'investigatorAffiliation': 'Queen Mary University of London'}}}}