Tests BR005-036C tablets against placebo for acute migraine in adults
Compares BR005-036C tablets with placebo in adults having acute migraine attacks.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Key facts
- Where
- Anhui, Beijing, Chongqing, Fujian, Gansu, Guangdong, Guangzhou, Hebei, Heilongjiang, Henan, Hubei, Hunan, Inner Mongolia, Jiangsu, Jilin City, Liaoning, Ningxia, Shandong, Shanghai, Shanxi, Sichuan, Tianjin, Xinjiang, Yunnan, and Zhejiang, ChinaSee the 83 sites
- Phase
- Phase 2/3
Where in China
- the First Affiliated Hospital of Bengbu Medical CollegeAnhui, ChinaNot yet recruiting
- The Second Affiliated Hospital of Anhui Medical UniversityAnhui, ChinaNot yet recruiting
- The Second People's Hospital of HefeiAnhui, ChinaNot yet recruiting
- Xuancheng People's HospitalAnhui, ChinaNot yet recruiting
- Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- First Medical Center of Chinese PLA General HospitalBeijing, ChinaTaking people
- Peking Union Medical College HospitalBeijing, ChinaNot yet recruiting
- Peking University People's HospitalBeijing, ChinaNot yet recruiting
- Peking University Third HospitalBeijing, ChinaNot yet recruiting
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting
- Chonggang General HospitalChongqing, ChinaNot yet recruiting
- Chongqing University Three Gorges HospitalChongqing, ChinaNot yet recruiting
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)Chongqing, ChinaNot yet recruiting
- The First Affiliated Hospital of Xiamen UniversityFujian, ChinaNot yet recruiting
- The 940th Hospital of PLA Joint Logistic Support ForceGansu, ChinaNot yet recruiting
- The Second Hospital of Lanzhou UniversityGansu, ChinaNot yet recruiting
- Guangzhou First People's HospitalGuangdong, ChinaNot yet recruiting
- Shenzhen People's HospitalGuangdong, ChinaNot yet recruiting
- Shenzhen Second People's HospitalGuangdong, ChinaNot yet recruiting
- The Second Affiliated Hospital of Guangzhou Medical UniversityGuangdong, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting
- Cangzhou Central HospitalHebei, ChinaNot yet recruiting
- Hebei General HospitalHebei, ChinaNot yet recruiting
- The Fourth Affiliated Hospital of Harbin Medical UniversityHeilongjiang, ChinaNot yet recruiting
- The First Affiliated Hospital of Henan University of Science and TechnologyHenan, ChinaNot yet recruiting
- The First Affiliated Hospital of Nanyang Medical CollegeHenan, ChinaNot yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityHenan, ChinaNot yet recruiting
- The Second People's Hospital of ZhengzhouHenan, ChinaNot yet recruiting
- Zhengzhou People's HospitalHenan, ChinaNot yet recruiting
- Huanggang Central HospitalHubei, ChinaNot yet recruiting
- Jingzhou First People's HospitalHubei, ChinaNot yet recruiting
- Renmin Hospital of Wuhan UniversityHubei, ChinaNot yet recruiting
- Taihe Hospital, ShiyanHubei, ChinaNot yet recruiting
- Wuhan Third Hospital (Wuhan Tongren Hospital)Hubei, ChinaNot yet recruiting
- Zhongnan Hospital of Wuhan UniversityHubei, ChinaNot yet recruiting
- Changde First People's HospitalHunan, ChinaNot yet recruiting
- Changsha Central HospitalHunan, ChinaNot yet recruiting
- Shaoyang Central HospitalHunan, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityHunan, ChinaNot yet recruiting
- The Third Hospital of ChangshaHunan, ChinaNot yet recruiting
- The Third Xiangya Hospital of Central South UniversityHunan, ChinaNot yet recruiting
- Xiangya Hospital of Central South UniversityHunan, ChinaNot yet recruiting
- Zhuzhou Central HospitalHunan, ChinaNot yet recruiting
- Inner Mongolia Autonomous Region People's HospitalInner Mongolia, ChinaNot yet recruiting
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyInner Mongolia, ChinaNot yet recruiting
- Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)Jiangsu, ChinaNot yet recruiting
- Nanjing Brain HospitalJiangsu, ChinaNot yet recruiting
- The First Affiliated Hospital of Soochow UniversityJiangsu, ChinaNot yet recruiting
- The Second Affiliated Hospital of Nanjing Medical UniversityJiangsu, ChinaTaking people
- The Second Affiliated Hospital of Soochow UniversityJiangsu, ChinaNot yet recruiting
- The Second People's Hospital of LianyungangJiangsu, ChinaNot yet recruiting
- Wuxi People's HospitalJiangsu, ChinaNot yet recruiting
- The Second Hospital of Jilin UniversityJilin City, ChinaNot yet recruiting
- Dalian Municipal Central Hospital, Affiliated to Dalian University of TechnologyLiaoning, ChinaNot yet recruiting
- General Hospital of Northern Theater Command of Chinese PLALiaoning, ChinaNot yet recruiting
- The People's Hospital of Liaoning ProvinceLiaoning, ChinaNot yet recruiting
- The First People's Hospital of YinchuanNingxia, ChinaNot yet recruiting
- Affiliated Hospital of Jining Medical UniversityShandong, ChinaNot yet recruiting
- Jinan Central HospitalShandong, ChinaNot yet recruiting
- Liaocheng People's HospitalShandong, ChinaNot yet recruiting
- Qilu Hospital of Shandong UniversityShandong, ChinaNot yet recruiting
- Qingdao Central HospitalShandong, ChinaNot yet recruiting
- Rizhao People's Hospital of Shandong ProvinceShandong, ChinaNot yet recruiting
- The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)Shandong, ChinaNot yet recruiting
- Zaozhuang Municipal HospitalShandong, ChinaNot yet recruiting
- Huashan Hospital, Fudan UniversityShanghai, ChinaNot yet recruiting
- Shanghai Fourth People's HospitalShanghai, ChinaNot yet recruiting
- Baoji Central HospitalShanxi, ChinaNot yet recruiting
- Shaanxi Provincial People's HospitalShanxi, ChinaNot yet recruiting
- The First Affiliated Hospital of Xi'an Medical UniversityShanxi, ChinaNot yet recruiting
- Xi'an Gaoxin HospitalShanxi, ChinaNot yet recruiting
- Xianyang Hospital of Yan'an UniversityShanxi, ChinaNot yet recruiting
- Dazhou Central HospitalSichuan, ChinaNot yet recruiting
- The First People's Hospital of ZigongSichuan, ChinaNot yet recruiting
- Tianjin People's HospitalTianjin, ChinaNot yet recruiting
- The Second Affiliated Hospital of Xinjiang Medical UniversityXinjiang, ChinaNot yet recruiting
- The First Affiliated Hospital of Kunming Medical UniversityYunnan, ChinaNot yet recruiting
- The second affiliated hospital of Kunming medical universityYunnan, ChinaNot yet recruiting
- Huzhou Central HospitalZhejiang, ChinaNot yet recruiting
- Rui'an People's HospitalZhejiang, ChinaNot yet recruiting
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineZhejiang, ChinaNot yet recruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineZhejiang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brise Pharmaceuticals Co., Ltd.
- Trial code
- NCT07792681
- Record updated
- 23 October 2026
- Original description
The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute MigrainesRead full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study Evaluating the Efficacy and Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults
The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines
Inclusion: 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.
Exclusion: 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); 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; 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; Abnormal electrocardiogram findings at screening: QTcF >450 msec for male subjects; QTcF >470 msec for female subjects.