Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-26 @ 1:25 PM
Study NCT ID:
NCT00797667
Status:
TERMINATED
Last Update Posted:
2018-10-18
First Post:
2008-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C525458', 'term': 'telcagepant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Based on a recommendation from the external Data Safety Monitoring Board (DSMB), a decision to terminate the trial was made on 26-Mar-2009.'}}, 'adverseEventsModule': {'timeFrame': 'up to 14 days after last dose of study drug (up to 12 weeks)', 'description': 'All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-0974 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks', 'otherNumAtRisk': 263, 'otherNumAffected': 61, 'seriousNumAtRisk': 263, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'MK-0974 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks', 'otherNumAtRisk': 265, 'otherNumAffected': 73, 'seriousNumAtRisk': 265, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks', 'otherNumAtRisk': 128, 'otherNumAffected': 30, 'seriousNumAtRisk': 128, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 42, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Colonic atony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Coordination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 263, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Monthly Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '-2.8'}, {'value': '-3.6', 'groupId': 'OG001', 'lowerLimit': '-4.1', 'upperLimit': '-3.1'}, {'value': '-2.4', 'groupId': 'OG002', 'lowerLimit': '-3.2', 'upperLimit': '-1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.', 'unitOfMeasure': 'Days per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Monthly Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-2.5'}, {'value': '-3.4', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '-3.0'}, {'value': '-2.3', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '-1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.', 'unitOfMeasure': 'Days per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '30.68', 'upperLimit': '43.02'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '33.92', 'upperLimit': '46.48'}, {'value': '25.6', 'groupId': 'OG002', 'lowerLimit': '18.22', 'upperLimit': '34.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Mean Monthly Migraine Attacks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '-1.7'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-2.2'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '-1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.', 'unitOfMeasure': 'attacks per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-2.5'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '-2.8'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.4', 'upperLimit': '-1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.', 'unitOfMeasure': 'Days per month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}, {'value': '57.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 14 days after last dose of study drug (up to 12 weeks)', 'description': 'Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '7.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks', 'description': 'Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'FG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '264'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '263'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '259'}, {'groupId': 'FG002', 'numSubjects': '127'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '656', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'BG001', 'title': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 20 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '20-29 years', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}]}, {'title': '60-64 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '551', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants who recieved at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'whyStopped': 'The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2009-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2008-11-24', 'resultsFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-04', 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Monthly Headache Days', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.'}, {'measure': 'Change From Baseline in Mean Monthly Migraine Days', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.'}, {'measure': 'Percentage of Participants Who Experienced an Adverse Event', 'timeFrame': 'up to 14 days after last dose of study drug (up to 12 weeks)', 'description': 'Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.'}, {'measure': 'Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event', 'timeFrame': 'up to 12 weeks', 'description': 'Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days', 'timeFrame': 'Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized'}, {'measure': 'Change From Baseline in the Mean Monthly Migraine Attacks', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.'}, {'measure': 'Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication', 'timeFrame': 'Baseline and Week 12', 'description': 'Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0974-049&kw=0974-049&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '25107879', 'type': 'RESULT', 'citation': 'Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, Lines C, Edvinsson L, Goadsby PJ, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958-66. doi: 10.1212/WNL.0000000000000771. Epub 2014 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient has had a history of migraine with or without aura\n* Patient is able to complete study questionnaire(s) and paper diary\n\nExclusion Criteria:\n\n* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study\n* Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions\n* Patient was older than 50 years of age at migraine onset\n* History of gastric or small intestinal surgery or has a disease that causes malabsorption\n* Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study\n* Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study\n* Currently participating in a study with MK-0974 or MK-3207'}, 'identificationModule': {'nctId': 'NCT00797667', 'briefTitle': 'MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase IIa, Multicenter, Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine', 'orgStudyIdInfo': {'id': '0974-049'}, 'secondaryIdInfos': [{'id': '2008_591'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telcagepant 140 mg', 'description': 'Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks', 'interventionNames': ['Drug: Telcagepant 140 mg', 'Drug: 280 mg telcagepant placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Telcagepant 280 mg', 'description': 'Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks', 'interventionNames': ['Drug: Telcagepant 280 mg', 'Drug: 140 mg telcagepant placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks', 'interventionNames': ['Drug: 140 mg telcagepant placebo', 'Drug: 280 mg telcagepant placebo']}], 'interventions': [{'name': 'Telcagepant 140 mg', 'type': 'DRUG', 'otherNames': ['MK-0974'], 'armGroupLabels': ['Telcagepant 140 mg']}, {'name': 'Telcagepant 280 mg', 'type': 'DRUG', 'otherNames': ['MK-0974'], 'armGroupLabels': ['Telcagepant 280 mg']}, {'name': '140 mg telcagepant placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Telcagepant 280 mg']}, {'name': '280 mg telcagepant placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Telcagepant 140 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}