Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT00604812
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2007-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
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': 'C093622', 'term': 'rizatriptan'}]}}, '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': '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': 'Pharmacokinetic data presented are preliminary data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rizatriptan 5 mg', 'description': 'Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rizatriptan 10 mg', 'description': 'Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.', 'otherNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Combined Placebo groups from panels A, B, and C.', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising of arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tiredenss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Painful left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevation in blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 5 mg', 'description': 'Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.'}, {'id': 'OG001', 'title': 'Rizatriptan 10 mg', 'description': 'Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Combined Placebo groups from panels A, B, and C.'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'No Adverse Events Reported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Hours', 'description': 'All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.'}, {'type': 'SECONDARY', 'title': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'OG001', 'title': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'OG002', 'title': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '84.0', 'spread': '19.8', 'groupId': 'OG001'}, {'value': '67.93', 'spread': '25.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot', 'unitOfMeasure': 'ng hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'OG001', 'title': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'OG002', 'title': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '5.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'OG001', 'title': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'OG002', 'title': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'OG001', 'title': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'OG002', 'title': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Apparent half-life (t½)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'FG001', 'title': 'Panel A Placebo', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.'}, {'id': 'FG002', 'title': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'FG003', 'title': 'Panel B Placebo', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.'}, {'id': 'FG004', 'title': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}, {'id': 'FG005', 'title': 'Panel C Placebo', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Panel C was added to the study by amendment after enrollment of Panels A and B were completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A', 'description': 'Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)'}, {'id': 'BG001', 'title': 'Panel B', 'description': 'Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)'}, {'id': 'BG002', 'title': 'Panel C', 'description': 'Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Ages 6 to <12', 'categories': [{'measurements': [{'value': '11', 'spread': '1.44', 'groupId': 'BG000'}, {'value': '2', 'spread': '2.14', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Ages 12 to 17', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'title': '20-39 kg', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': '≥ 40 kg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2007-10-17', 'resultsFirstSubmitDate': '2009-06-03', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-27', 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs', 'timeFrame': '24 Hours', 'description': 'All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)'}], 'secondaryOutcomes': [{'measure': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot'}, {'measure': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved'}, {'measure': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration'}, {'measure': 'Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)', 'timeFrame': '24 Hours', 'description': 'Preliminary pharmacokinetics data; Apparent half-life (t½)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '22289113', 'type': 'DERIVED', 'citation': 'Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.\n\nAfter completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines\n* Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines\n* Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration\n\nExclusion Criteria:\n\n* Subject has no history of migraine headaches\n* Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)\n* Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study'}, 'identificationModule': {'nctId': 'NCT00604812', 'briefTitle': 'Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years', 'orgStudyIdInfo': {'id': '0462-083'}, 'secondaryIdInfos': [{'id': '2007_601'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A Rizatriptan', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.', 'interventionNames': ['Drug: rizatriptan benzoate (5 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel A Placebo', 'description': 'Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.\n\nSubjects weighing 20-39 kg were allocated to Panel A.', 'interventionNames': ['Drug: Rizatriptan 5 mg Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B Rizatriptan', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.', 'interventionNames': ['Drug: rizatriptan benzoate (10 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel B Placebo', 'description': 'Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.\n\nSubjects weighing 40 kg and above were allocated to Panel B.', 'interventionNames': ['Drug: Rizatriptan 10 mg Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C Rizatriptan', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.', 'interventionNames': ['Drug: rizatriptan benzoate (5 mg)', 'Drug: rizatriptan benzoate (10 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel C Placebo', 'description': 'Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.\n\nPanel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.', 'interventionNames': ['Drug: Rizatriptan 5 mg Placebo', 'Drug: Rizatriptan 10 mg Placebo']}], 'interventions': [{'name': 'rizatriptan benzoate (5 mg)', 'type': 'DRUG', 'otherNames': ['MAXALT®', 'MK0462'], 'description': 'A single dose of rizatriptan 5 mg administered on Day 1.', 'armGroupLabels': ['Panel A Rizatriptan', 'Panel C Rizatriptan']}, {'name': 'rizatriptan benzoate (10 mg)', 'type': 'DRUG', 'otherNames': ['MAXALT®', 'MK0462'], 'description': 'A single dose of rizatriptan 10 mg administered on Day 1.', 'armGroupLabels': ['Panel B Rizatriptan', 'Panel C Rizatriptan']}, {'name': 'Rizatriptan 5 mg Placebo', 'type': 'DRUG', 'description': 'A single dose of rizatriptan 5 mg placebo administered on Day 1.', 'armGroupLabels': ['Panel A Placebo', 'Panel C Placebo']}, {'name': 'Rizatriptan 10 mg Placebo', 'type': 'DRUG', 'description': 'A single dose of rizatriptan 10 mg placebo administered on Day 1.', 'armGroupLabels': ['Panel B Placebo', 'Panel C Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}