Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-31 @ 6:48 AM
Study NCT ID:
NCT00095004
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2004-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C093622', 'term': 'rizatriptan'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2005-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2004-10-29', 'studyFirstSubmitQcDate': '2004-10-29', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who are pain free at 2 hours postdose'}, {'measure': 'Tolerability as measured by subjective adverse experience reporting'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with 24 hour sustained pain freedom'}, {'measure': 'Percentage of patients pain free at 30/45/60/90 minutes post dose'}, {'measure': 'Percentage of patients with associated symptoms at 2 hours'}, {'measure': 'Percentage of patients requiring rescue medication between 2 & 24 hours'}, {'measure': 'Percentage of patients with functional disability at 2 hours'}]}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '16732837', 'type': 'BACKGROUND', 'citation': 'Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24. doi: 10.1111/j.1526-4610.2006.00466.x.'}, {'pmid': '18005144', 'type': 'BACKGROUND', 'citation': 'Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. doi: 10.1111/j.1526-4610.2007.00947.x. Epub 2007 Nov 13.'}, {'pmid': '17681023', 'type': 'BACKGROUND', 'citation': 'Cady R, Martin V, Mauskop A, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. doi: 10.1111/j.1468-2982.2007.01391.x. Epub 2007 Aug 6.'}, {'pmid': '19222588', 'type': 'BACKGROUND', 'citation': 'Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.\n\nExclusion Criteria:\n\n* Heart disease\n* High blood pressure'}, 'identificationModule': {'nctId': 'NCT00095004', 'briefTitle': 'Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild', 'orgStudyIdInfo': {'id': '0462-066'}, 'secondaryIdInfos': [{'id': 'MK0462-066'}, {'id': '2004_089'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0462, rizatriptan benzoate / Duration of Treatment: 1day', 'type': 'DRUG'}, {'name': 'Comparator: placebo / Duration of Treatment: 1 day', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}