Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-03-04 @ 9:35 PM
Study NCT ID:
NCT03152305
Status:
UNKNOWN
Last Update Posted:
2017-05-15
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Pressure During Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], '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'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial pressure variations', 'timeFrame': 'during menstrual migraine attacks', 'description': 'Measured during menstrual migraine attacks compared to ICP in non-migraine days and in matched healthy women'}], 'secondaryOutcomes': [{'measure': 'Relationships between ICP variations and clinical parameters', 'timeFrame': 'during menstrual migraine attacks', 'description': 'Age, BMI, pain intensity, pulsating pain, allodynia, nausea, photophobia, phonophobia, dizziness, tinnitus'}, {'measure': 'Relationships between ICP variations and pain relief', 'timeFrame': 'during menstrual migraine attacks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Intracranial pressure', 'Headache'], 'conditions': ['Menstrual Migraine']}, 'descriptionModule': {'briefSummary': 'An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.', 'detailedDescription': 'Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 50 non menopausal women\n* Menstrual migraine\n* Using a triptan as usual treatment to relieve attacks\n* Usual triptan efficacy although recurrence is possible\n\nExclusion Criteria:\n\n* Disease of the ear\n* Intracranial hypertension\n* Chronic daily headache\n* Use of topiramate or acetazolamide\n* Triptans used more than 10 days/month\n* Analgesic drug used more than 15 days/month\n* Uncontrolled high blood pressure\n* BMI \\>30\n* Ongoing allergic rhinitis or flu'}, 'identificationModule': {'nctId': 'NCT03152305', 'acronym': 'MigICP', 'briefTitle': 'Intracranial Pressure During Migraine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Measure of Intracranial Pressure Variations During Migraine Attacks', 'orgStudyIdInfo': {'id': 'CHU-331'}, 'secondaryIdInfos': [{'id': '2014-A00042-45', 'type': 'OTHER', 'domain': '2014-A00042-45'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with menstrual migraine', 'description': 'Womens presenting with regular menstrual migraine treated with triptans will be included in the study.', 'interventionNames': ['Other: Intracranial pressure variations']}, {'label': 'Matched control', 'description': 'The potential variations will be compared to the measures done on matched healthy women outside and during menses.', 'interventionNames': ['Other: Intracranial pressure variations']}], 'interventions': [{'name': 'Intracranial pressure variations', 'type': 'OTHER', 'description': 'Self-measure of ICP will be performed outside and during menstrual migraine attacks.', 'armGroupLabels': ['Matched control', 'Women with menstrual migraine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'state': 'Auvergne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Pierre CLAVELOU', 'role': 'CONTACT', 'email': 'pclavelou@chu-clermontferrand.fr'}, {'name': 'Xavier MOISSET', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Pierre CLAVELOU', 'role': 'CONTACT', 'email': 'pclavelou@chu-clermontferrand.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}