Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults
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
1 other identifier
interventional
1,000
1 country
81
Brief Summary
The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 22, 2026
CompletedStudy Start
First participant enrolled
September 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
September 25, 2026
September 1, 2026
2.5 years
September 17, 2026
September 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.
Up to 52 weeks
Secondary Outcomes (3)
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
Study Arms (1)
BR005-036C
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Baoji Central Hospital
Shanxi, Baoji, 721008, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Inner Mongolia, Baotou, 014010, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
The First Affiliated Hospital of Bengbu Medical College
Anhui, Bengbu, 233004, China
Cangzhou Central Hospital
Hebei, Cangzhou, 061001, China
The Second Hospital of Jilin University
Jilin City, Changchun, 130022, China
The First People's Hospital of Changde
Hunan, Changde, 415003, China
The Third Hospital of Changsha
Hunan, Changsha, 410000, China
Changsha Central Hospital
Hunan, Changsha, 410004, China
Xiangya Hospital of Central South University
Hunan, Changsha, 410008, China
The Second Xiangya Hospital of Central South University
Hunan, Changsha, 410011, China
The Third Xiangya Hospital of Central South University
Hunan, Changsha, 410013, China
The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)
Chongqing, Chongqing Municipality, 400014, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chonggang General Hospital
Chongqing, Chongqing Municipality, 400084, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology
Liaoning, Dalian, 116033, China
Dazhou Central Hospital
Sichuan, Dazhou, 635000, China
Guangdong Provincial People's Hospital
Guangdong, Guangzhou, 510080, China
Guangzhou First People's Hospital
Guangdong, Guangzhou, 510180, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510260, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310009, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310016, China
The Fourth Affiliated Hospital of Harbin Medical University
Heilongjiang, Harbin, 150001, China
The Second People's Hospital of Hefei
Anhui, Hefei, 230011, China
The Second Affiliated Hospital of Anhui Medical University
Anhui, Hefei, 230601, China
Inner Mongolia Autonomous Region People's Hospital
Inner Mongolia, Hohhot, 010017, China
Huanggang Central Hospital
Hubei, Huanggang, 438000, China
Huzhou Central Hospital
Zhengjiang, Huzhou, 313000, China
Jinan Central Hospital
Shandong, Jinan, 250013, China
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Shandong, Jinan, 250014, China
Jingzhou First People's Hospital
Hubei, Jingzhou, 434000, China
Affiliated Hospital of Jining Medical University
Shandong, Jining, 272029, China
The Second Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650101, China
The Second Hospital of Lanzhou University
Gansu, Lanzhou, 730030, China
The 940th Hospital of PLA Joint Logistic Support Force
Gansu, Lanzhou, 730050, China
The Second People's Hospital of Lianyungang
Jiangsu, Lianyungang, 222023, China
Liaocheng People's Hospital
Shandong, Liaocheng, 252000, China
The First Affiliated Hospital of Henan University of Science and Technology
Henan, Luoyang, 471003, China
The Second Affiliated Hospital of Nanjing Medical University
Jiangsu, Nanjing, 210011, China
Nanjing Brain Hospital
Jiangsu, Nanjing, 210029, China
The First Affiliated Hospital of Nanyang Medical College
Henan, Nanyang, 473058, China
Qilu Hospital of Shandong University
Shandong, Qilu, 250012, China
Qingdao Central Hospital
Shandong, Qingdao, 266042, China
Rizhao People's Hospital of Shandong Province
Shandong, Rizhao, 276800, China
Rui'an People's Hospital
Zhejiang, Ruian, 325200, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434, China
Shaoyang Central Hospital
Hunan, Shaoyang, 422000, China
General Hospital of Northern Theater Command of Chinese PLA
Liaoning, Shenyang, 110016, China
The People's Hospital of Liaoning Province
Liaoning, Shenyang, 110016, China
Shenzhen People's Hospital
Guangdong, Shenzhen, 518020, China
Shenzhen Second People's Hospital
Guangdong, Shenzhen, 518035, China
Hebei General Hospital
Hebei, Shijiazhuang, 050051, China
Taihe Hospital, Shiyan
Hubei, Shiyan, 442000, China
The Second Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215004, China
The First Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215006, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
The Second Affiliated Hospital of Xinjiang Medical University
Xinjiang, Urumqi, 830017, China
Renmin Hospital of Wuhan University
Hubei, Wuhan, 430060, China
Wuhan Third Hospital (Wuhan Tongren Hospital)
Hubei, Wuhan, 430060, China
Zhongnan Hospital of Wuhan University
Hubei, Wuhan, 430077, China
Wuxi People's Hospital
Jiangsu, Wuxi, 214023, China
Shaanxi Provincial People's Hospital
Shanxi, Xi'an, 710068, China
Xi'an Gaoxin Hospital
Shanxi, Xi'an, 710075, China
The First Affiliated Hospital of Xi'an Medical University
Shanxi, Xi'an, 710077, China
The First Affiliated Hospital of Xiamen University
Fujian, Xiamen, 361003, China
Xianyang Hospital of Yan'an University
Shanxi, Xianyang, 712000, China
Xuancheng People's Hospital
Anhui, Xuancheng, 242000, China
The First People's Hospital of Yinchuan
Ningxia, Yinchuan, 750001, China
Zaozhuang Municipal Hospital
Shandong, Zaozhuang, 277102, China
Zhengzhou People's Hospital
Henan, Zhengzhou, 450003, China
The Second People's Hospital of Zhengzhou
Henan, Zhengzhou, 450015, China
The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450052, China
Zhuzhou Central Hospital
Hunan, Zhuzhou, 412007, China
The First People's Hospital of Zigong
Sichuan, Zigong, 643000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2026
First Posted
September 22, 2026
Study Start
September 30, 2026
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
September 25, 2026
Record last verified: 2026-09