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Not yet taking people in ChinaPhase 3

Long-term safety of BR005-036C tablets for migraine in adults

Tests BR005-036C tablets for long-term safety in adults with migraine.

Plain-language title generated from the registry record
Registry title: Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults

Key facts

Where
Anhui, Beijing, Chongqing, Fujian, Gansu, Guangdong, Hebei, Heilongjiang, Henan, Hubei, Hunan, Inner Mongolia, Jiangsu, Jilin City, Liaoning, Ningxia, Shandong, Shanghai, Shanxi, Sichuan, Tianjin, Xinjiang, Yunnan, Zhejiang, and Zhengjiang, ChinaSee the 81 sites
Phase
Phase 3

Where in China

  • the First Affiliated Hospital of Bengbu Medical CollegeAnhui, ChinaNo longer taking part
  • The Second Affiliated Hospital of Anhui Medical UniversityAnhui, ChinaNo longer taking part
  • The Second People's Hospital of HefeiAnhui, ChinaNo longer taking part
  • Xuancheng People's HospitalAnhui, ChinaNo longer taking part
  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
  • First Medical Center of Chinese PLA General HospitalBeijing, ChinaNo longer taking part
  • Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
  • Peking University People's HospitalBeijing, ChinaNo longer taking part
  • Peking University Third HospitalBeijing, ChinaNo longer taking part
  • Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
  • Chonggang General HospitalChongqing, ChinaNo longer taking part
  • Chongqing University Three Gorges HospitalChongqing, ChinaNo longer taking part
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNo longer taking part
  • The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)Chongqing, ChinaNo longer taking part
  • The First Affiliated Hospital of Xiamen UniversityFujian, ChinaNo longer taking part
  • The 940th Hospital of PLA Joint Logistic Support ForceGansu, ChinaNo longer taking part
  • The Second Hospital of Lanzhou UniversityGansu, ChinaNo longer taking part
  • Guangdong Provincial People'S HospitalGuangdong, ChinaNo longer taking part
  • Guangzhou First People's HospitalGuangdong, ChinaNo longer taking part
  • Shenzhen People's HospitalGuangdong, ChinaNo longer taking part
  • Shenzhen Second People's HospitalGuangdong, ChinaNo longer taking part
  • The Second Affiliated Hospital of Guangzhou Medical UniversityGuangdong, ChinaNo longer taking part
  • Cangzhou Central HospitalHebei, ChinaNo longer taking part
  • Hebei General HospitalHebei, ChinaNo longer taking part
  • The Fourth Affiliated Hospital of Harbin Medical UniversityHeilongjiang, ChinaNo longer taking part
  • The First Affiliated Hospital of Henan University of Science and TechnologyHenan, ChinaNo longer taking part
  • The First Affiliated Hospital of Nanyang Medical CollegeHenan, ChinaNo longer taking part
  • The First Affiliated Hospital of Zhengzhou UniversityHenan, ChinaNo longer taking part
  • The Second People's Hospital of ZhengzhouHenan, ChinaNo longer taking part
  • Zhengzhou People's HospitalHenan, ChinaNo longer taking part
  • Huanggang Central HospitalHubei, ChinaNo longer taking part
  • Jingzhou First People's HospitalHubei, ChinaNo longer taking part
  • Renmin Hospital of Wuhan UniversityHubei, ChinaNo longer taking part
  • Taihe Hospital, ShiyanHubei, ChinaNo longer taking part
  • Wuhan Third Hospital (Wuhan Tongren Hospital)Hubei, ChinaNo longer taking part
  • Zhongnan Hospital of Wuhan UniversityHubei, ChinaNo longer taking part
  • Changsha Central HospitalHunan, ChinaNo longer taking part
  • Shaoyang Central HospitalHunan, ChinaNo longer taking part
  • The First People's Hospital of ChangdeHunan, ChinaNo longer taking part
  • The Second Xiangya Hospital of Central South UniversityHunan, ChinaNo longer taking part
  • The Third Hospital of ChangshaHunan, ChinaNo longer taking part
  • The Third Xiangya Hospital of Central South UniversityHunan, ChinaNo longer taking part
  • Xiangya Hospital of Central South UniversityHunan, ChinaNo longer taking part
  • Zhuzhou Central HospitalHunan, ChinaNo longer taking part
  • Inner Mongolia Autonomous Region People's HospitalInner Mongolia, ChinaNo longer taking part
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyInner Mongolia, ChinaNo longer taking part
  • Nanjing Brain HospitalJiangsu, ChinaNo longer taking part
  • The First Affiliated Hospital of Soochow UniversityJiangsu, ChinaNo longer taking part
  • The Second Affiliated Hospital of Nanjing Medical UniversityJiangsu, ChinaNo longer taking part
  • The Second Affiliated Hospital of Soochow UniversityJiangsu, ChinaNo longer taking part
  • The Second People's Hospital of LianyungangJiangsu, ChinaNo longer taking part
  • Wuxi People's HospitalJiangsu, ChinaNo longer taking part
  • The Second Hospital of Jilin UniversityJilin City, ChinaNo longer taking part
  • Dalian Municipal Central Hospital, Affiliated to Dalian University of TechnologyLiaoning, ChinaNo longer taking part
  • General Hospital of Northern Theater Command of Chinese PLALiaoning, ChinaNo longer taking part
  • The People's Hospital of Liaoning ProvinceLiaoning, ChinaNo longer taking part
  • The First People's Hospital of YinchuanNingxia, ChinaNo longer taking part
  • Affiliated Hospital of Jining Medical UniversityShandong, ChinaNo longer taking part
  • Jinan Central HospitalShandong, ChinaNo longer taking part
  • Liaocheng People's HospitalShandong, ChinaNo longer taking part
  • Qilu Hospital of Shandong UniversityShandong, ChinaNo longer taking part
  • Qingdao Central HospitalShandong, ChinaNo longer taking part
  • Rizhao People's Hospital of Shandong ProvinceShandong, ChinaNo longer taking part
  • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)Shandong, ChinaNo longer taking part
  • Zaozhuang Municipal HospitalShandong, ChinaNo longer taking part
  • Huashan Hospital, Fudan UniversityShanghai, ChinaNo longer taking part
  • Shanghai Fourth People's HospitalShanghai, ChinaNo longer taking part
  • Baoji Central HospitalShanxi, ChinaNo longer taking part
  • Shaanxi Provincial People's HospitalShanxi, ChinaNo longer taking part
  • The First Affiliated Hospital of Xi'an Medical UniversityShanxi, ChinaNo longer taking part
  • Xi'an Gaoxin HospitalShanxi, ChinaNo longer taking part
  • Xianyang Hospital of Yan'an UniversityShanxi, ChinaNo longer taking part
  • Dazhou Central HospitalSichuan, ChinaNo longer taking part
  • The First People's Hospital of ZigongSichuan, ChinaNo longer taking part
  • Tianjin People's HospitalTianjin, ChinaNo longer taking part
  • The Second Affiliated Hospital of Xinjiang Medical UniversityXinjiang, ChinaNo longer taking part
  • The second affiliated hospital of Kunming medical universityYunnan, ChinaNo longer taking part
  • Rui'an People's HospitalZhejiang, ChinaNo longer taking part
  • Sir Run Run Shaw Hospital Zhejiang University School of MedicineZhejiang, ChinaNo longer taking part
  • The Second Affiliated Hospital Zhejiang University School of MedicineZhejiang, ChinaNo longer taking part
  • Huzhou Central HospitalZhengjiang, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Brise Pharmaceuticals Co., Ltd.
Trial code
NCT07835152
Record updated
25 September 2026
Original description
The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migrainesRead full original descriptionShow less

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

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

ClinicalTrials.gov NCT07835152