Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-31 @ 3:19 PM
Study NCT ID:
NCT00447369
Status:
WITHDRAWN
Last Update Posted:
2008-05-09
First Post:
2007-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pregabalin in Migraine Prevention
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': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'whyStopped': 'Because we did not find funds to do it', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-06', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2008-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'days with migraine'}], 'secondaryOutcomes': [{'measure': 'hours with migraine'}, {'measure': 'headache severity index'}, {'measure': 'level of disability'}, {'measure': 'reports of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pregabalin', 'Valproic acid', 'migraine', 'prophylaxis', 'prevention', 'treatment'], 'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '11251695', 'type': 'BACKGROUND', 'citation': 'Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, Stacey B, Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001 Feb;41(2):119-28. doi: 10.1046/j.1526-4610.2001.111006119.x.'}], 'seeAlsoLinks': [{'url': 'http://www.i-h-s.org/', 'label': 'International Headache Society'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.', 'detailedDescription': 'The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.\n* Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.\n* Available for follow-up at least 9 months.\n\nExclusion criteria:\n\n* Patients with headache others than migraine.\n* Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.\n* Prophylactic drugs for migraine 12 weeks before randomization.\n* Onset of migraine occurred after 50 years.\n* Hypersensitivity to pregabalin or sodium valproate.'}, 'identificationModule': {'nctId': 'NCT00447369', 'briefTitle': 'Efficacy of Pregabalin in Migraine Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Militar del General Luis Felipe Brieba Aran'}, 'orgStudyIdInfo': {'id': 'HM-PN-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pregabalin', 'type': 'DRUG'}, {'name': 'sodium valproate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '751-0021', 'city': 'Santiago', 'state': 'Reg. Metropolitana', 'country': 'Chile', 'facility': 'Hospital Militar del General Luis Felipe Brieba Aran', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Norberto Bilbeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Militar del General Luis Felipe Brieba Aran', 'class': 'OTHER'}}}}