Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT04804995
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2021-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache frequency', 'timeFrame': 'Daily headache diary in three months.', 'description': 'The frequency of headaches is higher in the first half of Ramadan month compared to the last half.'}, {'measure': 'Headache frequency', 'timeFrame': 'Daily headache diary in three months.', 'description': 'The frequency of headaches is higher in the month before Ramadan compared to the month after ramadan.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache', 'Migraine']}, 'descriptionModule': {'briefSummary': 'Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy participants and migraine patients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-60 years.\n* expectation of fasting for at least 21 of 30 days during the month of Ramadan.\n* understand and answer the questionnaire sent out in Danish.\n\nExclusion Criteria:\n\n* non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).'}, 'identificationModule': {'nctId': 'NCT04804995', 'briefTitle': 'Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Headache in Ramadan.', 'orgStudyIdInfo': {'id': 'Ramadan2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heathy participants', 'interventionNames': ['Other: There is no intervention.']}, {'label': 'migraine patients', 'interventionNames': ['Other: There is no intervention.']}], 'interventions': [{'name': 'There is no intervention.', 'type': 'OTHER', 'description': 'No intervention.', 'armGroupLabels': ['Heathy participants', 'migraine patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Faisal Mohammad Amin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mohammad Al-Mahdi Al-Karagholi', 'investigatorAffiliation': 'Danish Headache Center'}}}}