Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
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
1 other identifier
interventional
2,079
1 country
78
Brief Summary
The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2026
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
Study Completion
Last participant's last visit for all outcomes
July 31, 2028
August 28, 2026
August 1, 2026
1.8 years
August 24, 2026
August 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Freedom from Pain at 2 hours post-dose
2 hours post-dose
Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose
2 hours post-dose
Secondary Outcomes (6)
Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose
From 2 hours up to 24 hours post-dose
Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose
From 2 hours up to 48 hours post-dose
Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose
From 2 hours up to 24 hours post-dose
Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose
2 hours post-dose
Percentage of Participants with Pain Relief at 2 hours post-dose
2 hours post-dose
- +1 more secondary outcomes
Study Arms (3)
BR005-036C Dose 1
EXPERIMENTALBR005-036C Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
- 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.
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 (78)
The Second Central Hospital of Baoding
Hebei, Baoding, 072750, China
Baotou Central Hospital
Inner Mongolia, Baotou, 014040, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, 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 First Hospital of Jilin University
Jilin City, Changchun, 130021, China
The First People's Hospital of Changde
Hunan, Changde, 415003, 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
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, 400037, China
The First Affiliated Hospital of Dalian Medical University
Liaoning, Dalian, 116011, China
Dazhou Central Hospital
Sichuan, Dazhou, 635000, China
Fujian Medical University Union Hospital
Fujian, Fuzhou, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Sun Yat-sen University
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 Affiliated Hospital of Guizhou Medical University
Guizhou, Guiyang, 550004, China
Hainan General Hospital
Hainan, Haikou, 570311, China
The Fourth Affiliated Hospital of Harbin Medical University
Heilongjiang, Harbin, 150001, China
The Second People's Hospital of Hefei
Anhui, Hefei, 230011, China
Jinan Central Hospital
Shandong, Jinan, 250013, China
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Shandong, Jinan, 250014, China
The First People's Hospital of Jingzhou
Hubei, Jingzhou, 434000, China
Jingzhou Central Hospital
Hubei, Jingzhou, 434020, China
Affiliated Hospital of Jining Medical University
Shandong, Jining, 272029, China
The Second Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650101, 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
Linyi People's Hospital
Shandong, Linyi, 276003, China
Lu'an People's Hospital
Anhui, Lu'an, 237005, 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
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Jiangsu, Nanjing, 210029, China
Nanjing Brain Hospital
Jiangsu, Nanjing, 210029, China
The First Affiliated Hospital of Nanyang Medical College
Henan, Nanyang, 473058, China
Pingxiang People's Hospital
Jiangxi, Pingxiang, 337055, China
The Affiliated Hospital of Qingdao University
Shandong, Qingdao, 266003, China
Qingdao Central Hospital
Shandong, Qingdao, 266042, China
The Second Affiliated Hospital of Qiqihar Medical University
Heilongjiang, Qiqihar, 161006, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434, China
Shaoyang Central Hospital
Hunan, Shaoyang, 422000, China
The People's Hospital of Liaoning Province
Liaoning, Shenyang, 110016, China
The University of Hong Kong-Shenzhen Hospital
Guangdong, Shenzhen, 518053, China
The Second Hospital of Hebei Medical University
Hebei, Shijiazhuang, 050000, China
Hebei General Hospital
Hebei, Shijiazhuang, 050051, China
Sinopharm Dongfeng General Hospital
Hubei, Shiyan, 442008, China
The Second Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215004, China
The First Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215006, China
Shanxi Provincial Cardiovascular Hospital
Shanxi, Taiyuan, 030024, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121, China
Wenzhou People's Hospital
Zhejiang, Wenzhou, 325000, China
Renmin Hospital of Wuhan University
Hubei, Wuhan, 430060, China
Wuhan Third Hospital (Wuhan Tongren Hospital)
Hubei, Wuhan, 430060, China
Affiliated Hospital of Jiangnan University
Jiangsu, Wuxi, 214062, China
The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)
Shanxi, Xi'an, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Shanxi, Xi'an, 710061, 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
The First People's Hospital of Yinchuan
Ningxia, Yinchuan, 750001, China
General Hospital of Ningxia Medical University
Ningxia, Yinchuan, 750004, China
Zaozhuang Municipal Hospital
Shandong, Zaozhuang, 277102, China
Zhengzhou People's Hospital
Henan, Zhengzhou, 450003, 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 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2026
First Posted
August 28, 2026
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
August 28, 2026
Record last verified: 2026-08