Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-07 @ 9:13 PM
Study NCT ID:
NCT02901756
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of days with migraine headache at the 3rd Month', 'timeFrame': '3rd month of supplementation'}], 'secondaryOutcomes': [{'measure': 'Number of days with migraine headache per month', 'timeFrame': 'during the 1st month'}, {'measure': 'Number of days with migraine headache per month', 'timeFrame': 'during the 3rd month'}, {'measure': 'Intensity of migraine headache evaluated with a 5 points Likert Scale', 'timeFrame': 'during the 1st month'}, {'measure': 'Intensity of migraine headache evaluated with a 5 points Likert Scale', 'timeFrame': 'during the 3rd month'}, {'measure': 'Associated symptoms evaluated with Scorecard of potential symptoms', 'timeFrame': 'during the 1st month of observation, 1st, 2nd and 3rd month'}, {'measure': 'Associated symptoms evaluated with Scorecard of potential symptoms', 'timeFrame': 'during the 1st month'}, {'measure': 'Anxiety and depression evaluated with DNS (Dopa Nora Sero) questionnaire', 'timeFrame': 'during the 3rd month'}, {'measure': 'Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire', 'timeFrame': 'baseline'}, {'measure': 'Quality of life evaluated with the QVM (Quality of Life for Migraine) questionnaire', 'timeFrame': 'end of the 3rd month'}, {'measure': 'Compliance followed with patient logbook', 'timeFrame': '3 months'}, {'measure': 'Safety followed with side effects register', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '28854909', 'type': 'DERIVED', 'citation': 'Guilbot A, Bangratz M, Ait Abdellah S, Lucas C. A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study. BMC Complement Altern Med. 2017 Aug 30;17(1):433. doi: 10.1186/s12906-017-1933-7.'}]}, 'descriptionModule': {'briefSummary': 'Adult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.', 'detailedDescription': "Three visits were planned: V1, V2 on Day 30 (± 10) and V3 on Day 120 (± 10). On V1, after checking the inclusion criteria and receiving informed consent, GPs collected demographic data, medical and migraine history and information on migraine attacks, associated symptoms and rescue medications via an electronic case report form. V1 was followed by a one-month observation period (baseline phase) during which migraine treatment of patients was not modified. From V1 till the end of the study, all patients kept an electronic diary in which they reported migraine characteristics (number of days with migraine headache, intensity, associated symptoms and concomitant medications). On the second visit (V2; Day 30 ± 10), eligibility of patients was verified: patients with less than 2 or more than 15 migraine attacks during baseline phase and patients unwilling to be supplemented with the combination were excluded from the study. Eligible patients were advised to start supplementation. On V3 (Day 120 ± 10), information provided in patient's diary and compliance with supplementation were checked.\n\nThe day before V2 and V3, patients had to complete the French migraine-related quality of life questionnaire (Qualité de Vie et Migraine \\[QVM\\]) and the Hospital Anxiety and Depression Scale (HADS).\n\nThe study was conducted in accordance with articles L.1121-1 and R1121-2 of the French public health code defining non interventional studies; all the acts were practised and products used in a usual way without any additional or unusual procedure of diagnosis or surveillance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients were recruited by general practitioners (GPs). Patients had to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to suffer from migraine with or without aura diagnosed according to the criteria of the International Classification of Headaches Disorders III (ICHD III 1.1 and 1.2)\n* to suffer from migraine for more than one year\n* to be less than 50 years old at migraine onset\n* to have had at least two migraine attacks during the month before recruitment\n\nExclusion Criteria:\n\n* migraine with aura with motor symptoms (hemiplegic migraine)\n* more than 15 migraine attacks per month\n* abuse of painkillers defined as the use of paracetamol, aspirin and non-steroid anti-inflammatory drugs for more than 15 days per month over the last three months or the use of triptans, opioids and ergot-type medications for more than 10 days per month during the last three months\n* prophylactic treatment taken for less than 3 months'}, 'identificationModule': {'nctId': 'NCT02901756', 'briefTitle': 'A Combination of Coenzyme Q10, Feverfew and Magnesium for Migraine Prophylaxis : a Prospective Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'PiLeJe'}, 'orgStudyIdInfo': {'id': 'PiL-Obs-AntMIG-014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antemig', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants were instructed to take one tablet every morning for three months.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PiLeJe', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}