The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines
Male or female Participants aged 18 years or older.
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.
At least 2 migraine attacks need to treat per month within 3 months prior to screening visit.
Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.
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.
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.
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.
Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.
Single group
BR005-036C
DrugDose 1, Oral tablet, PRN
Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
Percentage of participants with Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) concurrent with Total Bilirubin > 2 x ULN during the treatment period
Number of participants with hepatic functional abnormal during the treatment period
Percentage of participants stratified by satisfaction level after BR005-036C treatment
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