[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brise Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100656983","phase-3-long-term-safety-of-br005-036c-tablets-in-the-acute-treatment-of-migraine-in-adults-100656983",false,"NCT07835152","Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults","A Multiple Center, Open-label Phase III Study to Evaluate Long-term Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults","Inclusion Criteria:\n\n1. Male or female Participants aged 18 years or older.\n2. Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year.\n3. At least 2 migraine attacks need to treat per month within 3 months prior to screening visit.\n4. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.\n5. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.\n\nExclusion Criteria:\n\n1. Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia.\n2. Patient with clinically significant cardiovascular, cerebrovascular, hematological, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological or psychiatric disorders; patient with other confounding acute or chronic pain syndromes, dementia, epilepsy, or other diseases (other than migraine) that may interfere with study assessments.\n3. Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis.\n4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.\n5. Abnormal electrocardiogram findings at screening: QTcF \\>450 msec for male subjects; QTcF \\>470 msec for female subjects.\n6. Patient with uncontrolled hypertension.\n7. History of alcohol or substance abuse within 6 months prior to screening.\n8. Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \\>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m².\n9. Use of CGRP receptor antagonists within 1 month prior to screening or randomization; use of anti-CGRP or anti-CGRP-receptor monoclonal antibodies within 6 months prior to screening or randomization.\n10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines",[26],"Migraine, With or Without Aura","NOT_YET_RECRUITING","2026-09-23",{"date":30,"type":31},"2026-09-25","ACTUAL",{"date":33,"type":20},"2026-09-30",{"date":35,"type":20},"2029-04-30",{"name":37,"class":38},"Brise Pharmaceuticals Co., Ltd.","INDUSTRY",81,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100653818","phase-2-efficacy-and-safety-of-br005-036c-tablets-for-the-acute-treatment-of-migraine-in-adults-100653818","NCT07792681","Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II\u002FIII Clinical Study Evaluating the Efficacy and Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults","Inclusion Criteria:\n\n1. Male or female Participants aged 18 years or older.\n2. Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year.\n3. Onset age of migraine shall be less than 50 years old.\n4. At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit.\n5. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.\n6. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.\n\nExclusion Criteria:\n\n1. Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia.\n2. Patient with clinically significant cardiovascular, cerebrovascular, hematological, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological or psychiatric disorders; patient with other confounding acute or chronic pain syndromes, dementia, epilepsy, or other diseases (other than migraine) that may interfere with study assessments.\n3. Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis.\n4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.\n5. Abnormal electrocardiogram findings at screening: QTcF \\>450 msec for male subjects; QTcF \\>470 msec for female subjects.\n6. Patient with uncontrolled hypertension.\n7. History of alcohol or substance abuse within 6 months prior to screening.\n8. Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \\>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m².\n9. Use of CGRP receptor antagonists within 1 month prior to screening or randomization; use of anti-CGRP or anti-CGRP-receptor monoclonal antibodies within 6 months prior to screening or randomization.\n10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).",{"count":48,"type":20},2079,[50,23],"PHASE2","The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines",[26],"2026-09-15",{"date":55,"type":31},"2026-09-16",{"date":53,"type":20},{"date":58,"type":20},"2028-07-31",{"name":37,"class":38},83,""]