Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04740827
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718987', 'term': 'atogepant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.', 'description': 'All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 158, 'otherNumAffected': 34, 'seriousNumAtRisk': 157, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 157, 'otherNumAffected': 40, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'BREAST CANCER STAGE II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'INVASIVE BREAST CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.86', 'spread': '0.389', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '0.397', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.43', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '-1.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.426', 'estimateComment': 'MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.85', 'spread': '0.388', 'groupId': 'OG000'}, {'value': '-4.20', 'spread': '0.393', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.35', 'ciLowerLimit': '-3.19', 'ciUpperLimit': '-1.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.425', 'estimateComment': 'MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.', 'unitOfMeasure': 'migraine days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.15', 'ciLowerLimit': '3.02', 'ciUpperLimit': '8.79', 'estimateComment': 'Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \\>2) as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.82', 'ciLowerLimit': '2.85', 'ciUpperLimit': '8.14', 'estimateComment': 'Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \\>2) as explanatory variables.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '-4.21', 'spread': '0.431', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.28', 'ciLowerLimit': '-3.15', 'ciUpperLimit': '-1.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.440', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.', 'unitOfMeasure': 'headache days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '-4.10', 'spread': '0.429', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.19', 'ciLowerLimit': '-3.05', 'ciUpperLimit': '-1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.439', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.', 'unitOfMeasure': 'headache days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '0.363', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.68', 'ciLowerLimit': '-3.43', 'ciUpperLimit': '-1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.381', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'acute medication use days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.358', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '0.361', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.61', 'ciLowerLimit': '-3.36', 'ciUpperLimit': '-1.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.380', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'acute medication use days per month', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.41', 'spread': '2.078', 'groupId': 'OG000'}, {'value': '33.09', 'spread': '2.102', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.67', 'ciLowerLimit': '13.05', 'ciUpperLimit': '22.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.348', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed are the number of participants available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.38', 'spread': '2.047', 'groupId': 'OG000'}, {'value': '33.26', 'spread': '2.065', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.88', 'ciLowerLimit': '13.34', 'ciUpperLimit': '22.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.308', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': "The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.97', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '-9.68', 'spread': '0.826', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.71', 'ciLowerLimit': '-6.37', 'ciUpperLimit': '-3.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.844', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.03', 'spread': '0.748', 'groupId': 'OG000'}, {'value': '-7.43', 'spread': '0.773', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.39', 'ciLowerLimit': '-5.94', 'ciUpperLimit': '-2.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.786', 'estimateComment': 'MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.14', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '-10.56', 'spread': '0.804', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.42', 'ciLowerLimit': '-8.22', 'ciUpperLimit': '-4.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.912', 'estimateComment': 'MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant\'s ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant\'s ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'OG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug (up to Week 12)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.'}, {'id': 'FG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}], 'periods': [{'title': 'Double-blind Treatment (Up to Week 12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'Safety Population', 'comment': 'Safety population consisted of all participants who received at least 1 dose of study intervention.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'Modified Intent-to-Treat (mITT) Population', 'comment': 'mITT population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the double-blind treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Off-treatment Hypothetical Estimand (OTHE) Population', 'comment': 'OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'Follow-up Period (Week 13 to Week 16)', 'milestones': [{'type': 'STARTED', 'comment': 'Of 295 participants who completed the double-blind period 87 participants entered the follow-up period. Participants who rolled over directly at Week 12 to study 3101-312-002 \\[NCT04686136\\] did not enter the safety-follow up period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 315 participants were randomized to receive atogepant-matching placebo or atogepant in a double-blind treatment period, and 313 participants received at least 1 dose of study intervention (safety population). From the 295 participants who completed the double-blind period 87 participants entered the follow-up period. Participants who rolled over directly at Week 12 to study 3101-312-002 \\[NCT04686136\\] did not enter the safety-follow up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'BG001', 'title': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.5', 'spread': '10.29', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '10.71', 'groupId': 'BG001'}, {'value': '42.1', 'spread': '10.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Monthly Migraine Days in mITT Population', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '2.41', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '2.30', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '2.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28.', 'unitOfMeasure': 'Migraine days per month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'mITT population included all randomized participants who received at least 1 dose of study intervention.'}, {'title': 'Monthly Migraine Days in OTHE Population', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '2.40', 'groupId': 'BG000'}, {'value': '9.1', 'spread': '2.29', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '2.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28.', 'unitOfMeasure': 'Migraine days per month', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention.'}], 'populationDescription': 'Intent-to-Treat (ITT) Population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-01', 'size': 2575394, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-03T10:52', 'hasProtocol': True}, {'date': '2022-08-21', 'size': 572649, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-03T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2021-02-02', 'resultsFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-19', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.'}, {'measure': 'Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.'}, {'measure': 'Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.'}, {'measure': 'Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.'}, {'measure': 'Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': 'Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.'}, {'measure': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': 'An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': "The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis."}, {'measure': 'Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': "The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis."}, {'measure': 'Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).'}, {'measure': 'Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population', 'timeFrame': 'Baseline to Week 12', 'description': 'The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).'}, {'measure': 'Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population', 'timeFrame': 'Baseline to Week 12', 'description': 'HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant\'s ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant\'s ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.'}, {'measure': 'Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug until 30 days after last dose of study drug (up to Week 12)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Episodic migraine'], 'conditions': ['Episodic Migraine']}, 'referencesModule': {'references': [{'pmid': '39982105', 'type': 'DERIVED', 'citation': 'Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.'}, {'pmid': '39715475', 'type': 'DERIVED', 'citation': 'Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.'}, {'pmid': '39648617', 'type': 'DERIVED', 'citation': 'Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.'}, {'pmid': '38364831', 'type': 'DERIVED', 'citation': 'Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.\n* Age of the participant at the time of migraine onset \\< 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment\n* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.\n* 4 to 14 migraine days in the 28-day baseline period per eDiary\n* Failed oral migraine prophylaxis medications from 2 to 4 medication classes\n\nExclusion Criteria:\n\n* Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease\n* Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder\n* In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine\n* Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment\n* Has ≥ 15 headache days in the 28-day baseline period per eDiary\n* Clinically significant cardiovascular or cerebrovascular disease\n* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018\n* Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018"}, 'identificationModule': {'nctId': 'NCT04740827', 'acronym': 'ELEVATE', 'briefTitle': 'Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)', 'orgStudyIdInfo': {'id': '3101-304-002'}, 'secondaryIdInfos': [{'id': '2019-003448-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atogepant 60 mg', 'description': 'Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.', 'interventionNames': ['Drug: Atogepant 60 mg']}], 'interventions': [{'name': 'Atogepant 60 mg', 'type': 'DRUG', 'description': 'Atogepant tablets.', 'armGroupLabels': ['Atogepant 60 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Atogepant matching placebo tablets.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Axiom Research /ID# 226379', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90720-3500', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90720-3500', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research, Inc /ID# 228386', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '80301-1880', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alpine Clinical Research Center /ID# 226201', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Sensible Healthcare /ID# 226197', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research /ID# 226224', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research /ID# 226302', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Velocity Clinical Research - Boise /ID# 226320', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Allied Physicians - Fort Wayne Neurological Center /ID# 226350', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic - Gateway Health Center /ID# 226481', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmasite Research, Inc. /ID# 226445', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': 'StudyMetrix Research /ID# 226297', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest Research LLC /ID# 226273', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Methodist Physicians Clinic /ID# 226470', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '08869', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amici Clinical Research - 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. 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