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NCT07835152
Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults
Conditions: Migraine, With or Without Aura
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1000
Sponsor: Brise Pharmaceuticals Co., Ltd.
Location: Baoji Central Hospital Shanxi Baoji
Summary
The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines
Eligibility Criteria
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) \
Source: ClinicalTrials.gov (NCT07835152). StuddyBuddy aggregates publicly available trial information.