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

Prior treatment

• 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.
• History of alcohol or substance abuse within 6 months prior to screening.
• 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.
• Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).

Other illness

• 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 uncontrolled hypertension.

Lab values

• Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m².

Other

• Abnormal electrocardiogram findings at screening: QTcF \>450 msec for male subjects; QTcF \>470 msec for female subjects.

• 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.
• Onset age of migraine shall be less than 50 years old.
• At least 2-8 moderate-to-severe migraine attacks 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.
• 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.