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Zhengzhou University","450052",{"type":51,"coordinates":583},[364,365],{"lat":365,"lon":364},{"facility":586,"status":11,"city":128,"state":587,"zip":588,"country":48,"countryCode":49,"cosmosGeoPoint":589,"geoPoint":591,"contacts":11},"Zhuzhou Central Hospital","Zhuzhou","412007",{"type":51,"coordinates":590},[133,134],{"lat":134,"lon":133},{"facility":593,"status":11,"city":202,"state":594,"zip":595,"country":48,"countryCode":49,"cosmosGeoPoint":596,"geoPoint":598,"contacts":11},"The First People's Hospital of Zigong","Zigong","643000",{"type":51,"coordinates":597},[207,208],{"lat":208,"lon":207},{"type":600,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":611,"type":612},1000,"ESTIMATED","INTERVENTIONAL",[615],"PHASE3","The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines",[618],"Migraine, With or Without Aura","NOT_YET_RECRUITING","2026-09-23",{"date":622,"type":623},"2026-09-25","ACTUAL",{"date":625,"type":612},"2026-09-30",{"date":627,"type":612},"2029-04-30",{"name":5,"class":6},81]