Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults

The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines

Inclusion Criteria: 1. Male or female Participants aged 18 years or older. 2. 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. 3. Onset age of migraine shall be less than 50 years old. 4. At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit. 5. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit. 6. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening. 5. Abnormal electrocardiogram findings at screening: QTcF \>450 msec for male subjects; QTcF \>470 msec for female subjects. 6. Patient with uncontrolled hypertension. 7. History of alcohol or substance abuse within 6 months prior to screening. 8. Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \