NCT07835152Not yet recruitingPhase 3
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
Brise Pharmaceuticals Co., Ltd.81 sites in 1 country1,000 target enrollmentStarted: September 30, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 81
- Primary Endpoint
- Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
Study Overview
Brief Summary
The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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
- •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.
- •Abnormal electrocardiogram findings at screening: QTcF >450 msec for male subjects; QTcF >470 msec for female subjects.
- •Patient with uncontrolled hypertension.
- •History of alcohol or substance abuse within 6 months prior to screening.
- •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.
- •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).
Arms & Interventions
BR005-036C
Experimental
Intervention: BR005-036C (Drug)
Outcomes
Primary Outcomes
Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
Time Frame: Up to 52 weeks
Secondary Outcomes
- 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(Up to 52 weeks)
- Number of participants with hepatic functional abnormal during the treatment period(Up to 52 weeks)
- Percentage of participants stratified by satisfaction level after BR005-036C treatment(Up to 52 weeks)
Investigators
Study Sites (81)
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