NCT07835152尚未招募3 期
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 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 81
- 主要终点
- Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
BR005-036C
Experimental
干预措施: BR005-036C (Drug)
结局指标
主要结局
Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
时间窗: Up to 52 weeks
次要结局
- 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)
研究者
研究点 (81)
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