Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-22 @ 12:06 AM
Study NCT ID:
NCT00662818
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2008-04-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Brazil', 'Chile', 'Colombia', 'Costa Rica', 'India', 'Italy', 'Mexico', 'Puerto Rico', 'Russia', 'Switzerland', 'Taiwan', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], '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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C525458', 'term': 'telcagepant'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 hours post-dose (Up to 14 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Telcagepant', 'description': 'Participants receiving telcagepant', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Acetaminophen/Paracetamol', 'description': 'Participants receiving acetaminophen/paracetamol', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '38.9'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '32.0'}]}]}], 'analyses': [{'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '0.62', 'ciUpperLimit': '4.25', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '76.4'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '70.2'}]}]}], 'analyses': [{'pValue': '0.420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.59', 'ciUpperLimit': '3.50', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Acetaminophen/Paracetamol (APAP)', 'description': 'Participants receiving APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days of any dose of study medication (Up to 16 weeks)', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'APAP', 'description': 'Participants receiving APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours post-dose (Up to 14 weeks)', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'APAP', 'description': 'Participants receiving APAP'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours after the dose of any study medication (Up to 14 weeks)', 'description': 'Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '78.0'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '71.9'}]}]}], 'analyses': [{'pValue': '0.648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.85', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for phonophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '39.5', 'upperLimit': '67.8'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '71.9'}]}]}], 'analyses': [{'pValue': '0.647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.07', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': '2 Hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for photophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '90.4'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '81.7'}]}]}], 'analyses': [{'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '0.73', 'ciUpperLimit': '4.60', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether nausea was present or absent at each of the predefined time points.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for nausea prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Telcagepant 300 mg', 'description': 'Participants receiving telcagepant'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '32.5'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '28.1'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.47', 'ciUpperLimit': '3.85', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 hours post-dose (Up to 14 weeks)', 'description': 'SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg', 'description': 'Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).'}, {'id': 'FG001', 'title': 'Placebo and APAP 1000 mg→Telcagepant 300 mg', 'description': 'Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).'}], 'periods': [{'title': 'Period 1 (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}, {'title': 'Wash-Out (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Period 2 (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Telcagepant 300 mg→APAP 1000 mg', 'description': 'Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).'}, {'id': 'BG001', 'title': 'Placebo and APAP 1000 mg→Telcagepant 300 mg', 'description': 'Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2009-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2008-04-17', 'resultsFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-15', 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose', 'timeFrame': 'Within 14 days of any dose of study medication (Up to 16 weeks)', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}, {'measure': 'Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose', 'timeFrame': 'Up to 48 hours post-dose (Up to 14 weeks)', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.'}, {'measure': 'Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose', 'timeFrame': 'Up to 48 hours after the dose of any study medication (Up to 14 weeks)', 'description': 'Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.'}, {'measure': 'Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.'}, {'measure': 'Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'timeFrame': '2 Hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.'}, {'measure': 'Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)', 'timeFrame': '2 hours post-dose (Up to 6 weeks)', 'description': 'The participant recorded whether nausea was present or absent at each of the predefined time points.'}, {'measure': 'Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose', 'timeFrame': 'Up to 24 hours post-dose (Up to 14 weeks)', 'description': 'SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Migraine Disorders', 'Heart Disease', 'Cerebrovascular Accident', 'TIA (Transient Ischemic Attack)', 'Vascular Diseases', 'Peripheral Vascular Diseases']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0974-034&kw=0974-034&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '22221076', 'type': 'DERIVED', 'citation': 'Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable coronary artery disease for 3 months or more\n* 18 years of age or older with a history of migraine with or without aura\n* Must use acceptable contraception throughout the study\n\nExclusion Criteria:\n\n* Pregnant, breast-feeding, or planning to become pregnant during this study\n* 50 years of age or older when migraines began\n* Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)\n* History of gastric, or small intestinal surgery, or has a disease that causes malabsorption'}, 'identificationModule': {'nctId': 'NCT00662818', 'briefTitle': 'Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease', 'orgStudyIdInfo': {'id': '0974-034'}, 'secondaryIdInfos': [{'id': 'MK-0974-034', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2007_545', 'type': 'OTHER', 'domain': 'Telerx ID Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg', 'description': 'Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.', 'interventionNames': ['Drug: Telcagepant', 'Drug: Acetaminophen/Paracetamol', 'Drug: Placebo to Telcagepant', 'Drug: Placebo to Acetaminophen/Paracetamol']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo and APAP 1000 mg→Telcagepant 300 mg', 'description': 'Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.', 'interventionNames': ['Drug: Telcagepant', 'Drug: Acetaminophen/Paracetamol', 'Drug: Placebo to Telcagepant', 'Drug: Placebo to Acetaminophen/Paracetamol']}], 'interventions': [{'name': 'Telcagepant', 'type': 'DRUG', 'description': 'Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)', 'armGroupLabels': ['Placebo and APAP 1000 mg→Telcagepant 300 mg', 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg']}, {'name': 'Acetaminophen/Paracetamol', 'type': 'DRUG', 'description': 'Acetaminophen/Paracetamol (500 mg X 2 dosage units)', 'armGroupLabels': ['Placebo and APAP 1000 mg→Telcagepant 300 mg', 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg']}, {'name': 'Placebo to Telcagepant', 'type': 'DRUG', 'description': 'Placebo 300 mg soft gel capsules or placebo 280 mg tablet.', 'armGroupLabels': ['Placebo and APAP 1000 mg→Telcagepant 300 mg', 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg']}, {'name': 'Placebo to Acetaminophen/Paracetamol', 'type': 'DRUG', 'description': 'Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)', 'armGroupLabels': ['Placebo and APAP 1000 mg→Telcagepant 300 mg', 'Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg']}]}, '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'}}}}