Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT00846495
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000077236', 'term': 'Topiramate'}, {'id': 'C108128', 'term': 'frovatriptan'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbrowning@clinvest.com', 'phone': '417-841-3664', 'title': 'Rebecca Browning', 'organization': 'Clinvest'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.', 'otherNumAtRisk': 28, 'otherNumAffected': 17, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.', 'otherNumAtRisk': 27, 'otherNumAffected': 5, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concentration Problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory Problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness in Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste Aversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling in Extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Migraine attacks', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Month 2', 'description': 'Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2', 'unitOfMeasure': 'Migraine attacks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Migraine attacks', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.'}, {'type': 'PRIMARY', 'title': 'Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '2.79', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Month 2', 'description': 'Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine', 'unitOfMeasure': 'Headache Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Headache Days Each Month Following Initiation of Treatment With Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Headache Days', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'title': 'Treatment Month 1', 'categories': [{'measurements': [{'value': '4.20', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '3.96', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Month 2', 'categories': [{'measurements': [{'value': '1.75', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '2.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 Months', 'description': 'Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication', 'unitOfMeasure': 'Headache Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Headache Days', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'title': 'Migraine Attacks Treatment Month 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Headache Days Treatment Month 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Migraine Attacks Treatment Month 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Headache Days Treatment Month 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 Months', 'description': 'Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life in Subjects Utilizing Each Treatment Paradigm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'title': 'Role Function Restrictive - Baseline', 'categories': [{'measurements': [{'value': '56.00', 'spread': '15.88', 'groupId': 'OG000'}, {'value': '59.88', 'spread': '16.65', 'groupId': 'OG001'}]}]}, {'title': 'Role Function Restrictive - Treatment Month 1', 'categories': [{'measurements': [{'value': '80.29', 'spread': '19.33', 'groupId': 'OG000'}, {'value': '66.48', 'spread': '18.75', 'groupId': 'OG001'}]}]}, {'title': 'Role Function Restrictive - Treatment Month 2', 'categories': [{'measurements': [{'value': '86.64', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '71.84', 'spread': '19.57', 'groupId': 'OG001'}]}]}, {'title': 'Role Function Preventive - Baseline', 'categories': [{'measurements': [{'value': '77.75', 'spread': '16.02', 'groupId': 'OG000'}, {'value': '77.50', 'spread': '18.53', 'groupId': 'OG001'}]}]}, {'title': 'Role Function Preventive - Treatment Month 1', 'categories': [{'measurements': [{'value': '85.25', 'spread': '18.32', 'groupId': 'OG000'}, {'value': '79.25', 'spread': '21.96', 'groupId': 'OG001'}]}]}, {'title': 'Role Function Preventive - Treatment Month 2', 'categories': [{'measurements': [{'value': '93.95', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '84.96', 'spread': '16.67', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Function - Baseline', 'categories': [{'measurements': [{'value': '60.67', 'spread': '22.47', 'groupId': 'OG000'}, {'value': '64.71', 'spread': '23.13', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Function - Treatment Month 1', 'categories': [{'measurements': [{'value': '80.00', 'spread': '25.68', 'groupId': 'OG000'}, {'value': '73.18', 'spread': '21.59', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Function - Treatment Month 2', 'categories': [{'measurements': [{'value': '91.46', 'spread': '10.49', 'groupId': 'OG000'}, {'value': '75.10', 'spread': '24.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization, End of Treatment Month 1, End of Treatment Month 2', 'description': 'Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction With Study Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'title': 'Efficacy', 'categories': [{'measurements': [{'value': '76.7857', 'spread': '21.04', 'groupId': 'OG000'}, {'value': '75.1977', 'spread': '30.21', 'groupId': 'OG001'}]}]}, {'title': 'Functionality', 'categories': [{'measurements': [{'value': '77.8214', 'spread': '22.68', 'groupId': 'OG000'}, {'value': '76.3648', 'spread': '29.98', 'groupId': 'OG001'}]}]}, {'title': 'Ease of Use', 'categories': [{'measurements': [{'value': '91.6607', 'spread': '11.5639', 'groupId': 'OG000'}, {'value': '92.6989', 'spread': '11.36', 'groupId': 'OG001'}]}]}, {'title': 'Cost', 'categories': [{'measurements': [{'value': '81.2536', 'spread': '19.85', 'groupId': 'OG000'}, {'value': '59.0886', 'spread': '32.86', 'groupId': 'OG001'}]}]}, {'title': 'Bothersomeness of Side Effects', 'categories': [{'measurements': [{'value': '95.1786', 'spread': '6.08', 'groupId': 'OG000'}, {'value': '95.5398', 'spread': '6.81', 'groupId': 'OG001'}]}]}, {'title': 'Total Score', 'categories': [{'measurements': [{'value': '82.0925', 'spread': '15.77', 'groupId': 'OG000'}, {'value': '81.1417', 'spread': '21.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Month 2', 'description': 'Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.\n\nParticipants completed the PPMQ 24 hours following each first dose of frovatriptan.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events Associated With Study Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Adverse Events', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Months 1 and 2', 'description': 'Includes Adverse Events at or above 5% frequency per group.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Adverse Events', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'OG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'classes': [{'title': 'Preventive Medication Taken', 'categories': [{'measurements': [{'value': '343.56', 'spread': '50.4774', 'groupId': 'OG000'}, {'value': '101.41', 'spread': '10.304', 'groupId': 'OG001'}]}]}, {'title': 'Rescue Medication Taken', 'categories': [{'measurements': [{'value': '38.33', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '59.94', 'spread': '9.54', 'groupId': 'OG001'}]}]}, {'title': 'All Study Medication Taken', 'categories': [{'measurements': [{'value': '381.89', 'spread': '51.8816', 'groupId': 'OG000'}, {'value': '161.35', 'spread': '70.1844', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Months 1 and 2', 'description': 'Average cost of study medication taken by each subject. Measured in dollars.', 'unitOfMeasure': 'Dollars (US)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'FG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topiramate', 'description': 'Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.'}, {'id': 'BG001', 'title': 'Frovatriptan', 'description': 'Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.61', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '37.33', 'spread': '9.46', 'groupId': 'BG001'}, {'value': '37.47', 'spread': '9.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-11', 'studyFirstSubmitDate': '2009-02-17', 'resultsFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-12', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate', 'timeFrame': 'Treatment Month 2', 'description': 'Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2'}, {'measure': 'Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine', 'timeFrame': 'Treatment Month 2', 'description': 'Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine'}], 'secondaryOutcomes': [{'measure': 'Number of Headache Days Each Month Following Initiation of Treatment With Study Medication', 'timeFrame': '2 Months', 'description': 'Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication'}, {'measure': 'Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm', 'timeFrame': '2 Months', 'description': 'Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2'}, {'measure': 'Quality of Life in Subjects Utilizing Each Treatment Paradigm', 'timeFrame': 'Randomization, End of Treatment Month 1, End of Treatment Month 2', 'description': 'Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.'}, {'measure': 'Participant Satisfaction With Study Medications', 'timeFrame': 'Treatment Month 2', 'description': 'Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.\n\nParticipants completed the PPMQ 24 hours following each first dose of frovatriptan.'}, {'measure': 'Adverse Events Associated With Study Medications', 'timeFrame': 'Treatment Months 1 and 2', 'description': 'Includes Adverse Events at or above 5% frequency per group.'}, {'measure': 'Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine', 'timeFrame': 'Treatment Months 1 and 2', 'description': 'Average cost of study medication taken by each subject. Measured in dollars.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'Migraine prevention', 'Prodrome', 'Premonitory phase', 'Preemptive therapy'], 'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '10961768', 'type': 'BACKGROUND', 'citation': 'Luciani R, Carter D, Mannix L, Hemphill M, Diamond M, Cady R. Prevention of migraine during prodrome with naratriptan. Cephalalgia. 2000 Mar;20(2):122-6. doi: 10.1046/j.1468-2982.2000.00030.x.'}]}, 'descriptionModule': {'briefSummary': 'Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n1. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)\n2. Subject has a 3-month history of averaging 3-6 migraines per month\n3. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches\n4. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.\n5. Male or female at least 18 years of age\n6. Subject of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of frovatriptan and topiramate.\n7. Subject is aware of prodrome symptoms that may include physiological, psychological or cognitive changes. These may include, but are not limited to such symptoms as Pre-Menstrual Syndrome (PMS), change in mood, energy level, appetite, food craving, nausea, sense of hearing, sense of smell or swelling/fluid retention, excessive yawning, head pain, muscle pain/tenderness, irritability, confusion, extreme sleepiness, impaired speech or impaired memory. (The subject should be able to differentiate these symptoms from other similar symptoms that do not precede migraine). The symptoms should precede migraine by 4-24 hours signaling an impending migraine attack.\n8. Subject is able to understand instructions for the study and complete the diary\n9. Subject is willing to give informed consent to participate in the study\n10. Any migraine prophylactic medication must have a stabilized dosage for one month\n\nEXCLUSION CRITERIA\n\n1. History of any medical condition that would confound the results of the study including but not limited to the following:\n\n * Hepatic disease or significant hepatic dysfunction\n * History of pancreatitis\n * History of thrombocytopenia\n * History of glaucoma\n * History of osteoporosis or osteopenia\n * Cardiovascular Disease - Coronary artery disease, Ischemic heart disease or Significant Arrhythmia\n * History of active Cerebrovascular Disease\n * Hypertension - Uncontrolled hypertension in a non-migrainous state (\\> 160 mmHg systolic or \\>95 mmHg. diastolic). Hypertension must be controlled effectively with medication for a period of 3 months.\n * Basilar or Hemiplegic Migraine\n * Significant peripheral vascular disease or Raynaud\'s Syndrome\n * Significant Active Renal, Hepatic, Gastrointestinal, Endocrine or\n * Neurological Disease\n * History of depression, mood problems or suicidal thoughts or behavior that in the opinion of the Investigator would interfere with participation in the study.\n2. History of ergotamine, "triptan", or analgesic abuse within past 3 months\n3. History of current or recent drug or alcohol abuse that would interfere with participation in the study.\n4. More than 15 headache days per month within past 3 months.\n5. Women who are pregnant or breast feeding\n6. Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication\n7. Subject is scheduled for surgical procedure to occur while enrolled in study.that in opinion of the Investigator would interfere with participation in the study.\n8. Subject is on a ketogenic diet\n9. Participation in another investigative drug study within the previous 30 days\n10. Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.'}, 'identificationModule': {'nctId': 'NCT00846495', 'briefTitle': 'Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine', 'organization': {'class': 'INDIV', 'fullName': 'Cady, Roger, M.D.'}, 'officialTitle': 'A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine', 'orgStudyIdInfo': {'id': 'Frova vs. Topiramate'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'topiramate', 'description': 'Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily.', 'interventionNames': ['Drug: topiramate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'frovatriptan', 'description': 'Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).', 'interventionNames': ['Drug: frovatriptan']}], 'interventions': [{'name': 'topiramate', 'type': 'DRUG', 'otherNames': ['Topamax'], 'description': 'topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks', 'armGroupLabels': ['topiramate']}, {'name': 'frovatriptan', 'type': 'DRUG', 'otherNames': ['Frova'], 'description': 'frovatriptan 5mg tab during premonitory phase of migraine', 'armGroupLabels': ['frovatriptan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Physician Associates LLC', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'overallOfficials': [{'name': 'Roger K Cady, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinvest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinvest', 'class': 'INDIV'}, 'collaborators': [{'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CEO', 'investigatorFullName': 'Clinvest', 'investigatorAffiliation': 'Cady, Roger, M.D.'}}}}