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NOT YET RECRUITING

NCT07835152

PHASE3

Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults

Sponsor: Brise Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-09-30

Completion Date

2029-04-30

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Migraine, With or Without Aura

Interventions

DRUG

BR005-036C

Oral tablet

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. At least 2 migraine attacks need to treat per month within 3 months prior to screening visit. 4. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit. 5. 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) \<60 mL/min/1.73 m². 9. 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. 10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).

Locations (81)

Baoji Central Hospital

Shanxi, Baoji, China

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Inner Mongolia, Baotou, China

Peking University People's Hospital