Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-28 @ 9:00 AM
Study NCT ID:
NCT00897104
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
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': 'C093622', 'term': 'rizatriptan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No limitations were encountered in this study.'}}, 'adverseEventsModule': {'timeFrame': 'During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.', 'description': 'Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.\n\nThe At Risk population are the participants that received study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack', 'otherNumAtRisk': 355, 'otherNumAffected': 92, 'seriousNumAtRisk': 355, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack', 'otherNumAtRisk': 357, 'otherNumAffected': 108, 'seriousNumAtRisk': 357, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack', 'otherNumAtRisk': 80, 'otherNumAffected': 16, 'seriousNumAtRisk': 80, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asthenia/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Pain, Abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Pain, Chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Warm Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Pain, Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Heaviness, Regional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Pain, Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Pain, Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Dream Abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Hypesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Mental Acuity Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Discomfort, Pharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 357, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CRISP Dictionary'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Relief at 2 Hours After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': '2-hour pain relief', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour pain relief', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all-participants-treated" approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.'}, {'type': 'PRIMARY', 'title': 'Time to Relief Within 2 Hours After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': 'First pain relief within 2 hrs', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Pain relief did not occur within 2 hrs', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 2 hours after treatment', 'description': 'Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all-participants-treated" approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.'}, {'type': 'SECONDARY', 'title': 'Pain Free at 2 Hours After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': '2-hour pain freedom', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour pain freedom', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Participants pain free (defined as a reduction of headache severity to grade 0 \\[no pain\\]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all-participants-treated" approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.'}, {'type': 'SECONDARY', 'title': 'Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Mildly Impaired', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Severely Impaired', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Required Bed Rest', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all-participants-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.'}, {'type': 'SECONDARY', 'title': 'Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': '2-hour Photophobia', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour Photophobia', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': '2-hour Phonophobia', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour Phonophobia', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': '2-hour Nausea', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour Nausea', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Not Analyzed for Nausea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '2-hour Vomiting', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'No 2-hour Vomiting', 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Not Analyzed for Vomiting', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '"All-participants-treated" approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.'}, {'type': 'SECONDARY', 'title': 'Participants Who Used Escape Medication 2 Hours After the Treatment Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'title': 'Used Escape Medication', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Did not Use Escape Medication', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An "all-participants-treated" approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.'}, {'type': 'SECONDARY', 'title': 'Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'classes': [{'categories': [{'measurements': [{'value': '11.07', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '11.58', 'spread': '5.86', 'groupId': 'OG001'}, {'value': '14.38', 'spread': '5.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'FG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who were allocated study drug', 'groupId': 'FG000', 'numSubjects': '418'}, {'comment': 'Participants who were allocated study drug', 'groupId': 'FG001', 'numSubjects': '428'}, {'comment': 'Participants who were allocated study drug', 'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'Participants Treated', 'achievements': [{'comment': 'Participants who took study drug', 'groupId': 'FG000', 'numSubjects': '355'}, {'comment': 'Participants who took study drug', 'groupId': 'FG001', 'numSubjects': '357'}, {'comment': 'Participants who took study drug', 'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'Participants Not Treated', 'achievements': [{'comment': 'Participants who did not take study drug', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': 'Participants who did not take study drug', 'groupId': 'FG001', 'numSubjects': '71'}, {'comment': 'Participants who did not take study drug', 'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who took study drug and completed the study', 'groupId': 'FG000', 'numSubjects': '354'}, {'comment': 'Participants who took study drug and completed the study', 'groupId': 'FG001', 'numSubjects': '357'}, {'comment': 'Participants who took study drug and completed the study', 'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Abnormal Prestudy Labs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal Baseline ECG', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Need for Concom. Med.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Migraine Attack', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No Longer Met Inc/Exc Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at 31 sites: 6 in UK, 9 in Norway, 2 in Switzerland, and 14 in Sweden\n\nFirst Participant Treated: August 1995\n\nLast Participant Treated: May 1996.', 'preAssignmentDetails': 'Participants screened at a pretreatment visit were given allocated drug supply with instructions. If participants had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled participants still had not treated an attack, they were discontinued from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '792', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rizatriptan 5 mg', 'description': 'Rizatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'BG001', 'title': 'Sumatriptan 5 mg', 'description': 'Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '652', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '356', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '788', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Headache Severity', 'classes': [{'title': 'Grades 0,1: no pain, Mild, or missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Grade 2: Moderate', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}]}, {'title': 'Grade 3: Severe', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 933}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '1996-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2009-05-08', 'resultsFirstSubmitDate': '2009-09-26', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-06-22', 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1996-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Relief at 2 Hours After Treatment', 'timeFrame': '2 hours after treatment', 'description': 'Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment'}, {'measure': 'Time to Relief Within 2 Hours After Treatment', 'timeFrame': 'within 2 hours after treatment', 'description': 'Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).'}], 'secondaryOutcomes': [{'measure': 'Pain Free at 2 Hours After Treatment', 'timeFrame': '2 hours after treatment', 'description': 'Participants pain free (defined as a reduction of headache severity to grade 0 \\[no pain\\]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).'}, {'measure': 'Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities', 'timeFrame': '2 hours after treatment', 'description': 'Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).'}, {'measure': 'Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment', 'timeFrame': '2 hours after treatment', 'description': 'Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.'}, {'measure': 'Participants Who Used Escape Medication 2 Hours After the Treatment Dose', 'timeFrame': '2 hours after treatment', 'description': 'Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.'}, {'measure': 'Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])', 'timeFrame': '24 hours', 'description': 'Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence'}]}, 'conditionsModule': {'conditions': ['Migraine Headache']}, 'referencesModule': {'references': [{'pmid': '19210513', 'type': 'BACKGROUND', 'citation': 'Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.'}, {'pmid': '11422095', 'type': 'RESULT', 'citation': 'Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.'}, {'pmid': '11284464', 'type': 'RESULT', 'citation': 'Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.'}]}, 'descriptionModule': {'briefSummary': 'A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant had at least a 6-month history of migraine, with or without aura\n* Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions\n* Participant was judged to be in good health, apart from migraine\n\nExclusion Criteria:\n\n* Participant was Pregnant or a nursing mother\n* Participant had a history or current evidence of drug or alcohol abuse\n* Participant had a history or clinical evidence of cardiovascular disease\n* Participant had a clinically significant Electrocardiography (ECG) abnormality\n* Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening\n* Participant had received treatment with an investigational device or compound within 30 days of the study\n* Participant typically suffered from less then 1 or more than 8 attacks of migraine per month\n* Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches\n* Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium'}, 'identificationModule': {'nctId': 'NCT00897104', 'briefTitle': 'MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': '0462-029'}, 'secondaryIdInfos': [{'id': '2009_593'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rizatriptan', 'interventionNames': ['Drug: rizatriptan benzoate (MK0462)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Sumatriptan', 'interventionNames': ['Drug: Comparator: sumatriptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'rizatriptan benzoate (MK0462)', 'type': 'DRUG', 'otherNames': ['MK0462'], 'description': 'single dose 5 mg rizatriptan p.o.', 'armGroupLabels': ['1']}, {'name': 'Comparator: sumatriptan', 'type': 'DRUG', 'description': 'single dose 50 mg sumatriptan p.o.', 'armGroupLabels': ['2']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}