Migraine, With or Without AuraPhase 2/3NCT07792681
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
A Phase 2/3 study testing BR005-036C in people with Migraine, With or Without Aura, run by Brise Pharmaceuticals Co., Ltd. at 83 sites in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, With or Without Aura
- What is being tested?
- BR005-036C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,079 participants
- Where
- 83 sitesChina
- Study dates
- 30 Sep 2026to 31 Jul 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
83 sites in 1 country. Contact the study team or a site near you to ask about taking part.
83 sites in 1 country
China83 sites, 83 recruiting
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Anhui, Bengbu, 233004
- Not yet recruiting
The Second People's Hospital of Hefei
Anhui, Hefei, 230011
- Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Anhui, Hefei, 230601
- Not yet recruiting
Xuancheng People's Hospital
Anhui, Xuancheng, 242000
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
- Recruiting
First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
- Not yet recruiting
The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)
Chongqing, Chongqing Municipality, 400014
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
- Not yet recruiting
Chonggang General Hospital
Chongqing, Chongqing Municipality, 400084
- Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Fujian, Xiamen, 361003
- Not yet recruiting
The Second Hospital of Lanzhou University
Gansu, Lanzhou, 730030
- Not yet recruiting
The 940th Hospital of PLA Joint Logistic Support Force
Gansu, Lanzhou, 730050
- Not yet recruiting
Guangzhou First People's Hospital
Guangdong, Guangzhou, 510180
- Not yet recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510260
- Not yet recruiting
Shenzhen People's Hospital
Guangdong, Shenzhen, 518020
- Not yet recruiting
Shenzhen Second People's Hospital
Guangdong, Shenzhen, 518035
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
- Not yet recruiting
Cangzhou Central Hospital
Hebei, Cangzhou, 061001
- Not yet recruiting
Hebei General Hospital
Hebei, Shijiazhuang, 050051
- Not yet recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Heilongjiang, Harbin, 150001
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Henan, Luoyang, 471003
- Not yet recruiting
The First Affiliated Hospital of Nanyang Medical College
Henan, Nanyang, 473058
- Not yet recruiting
Zhengzhou People's Hospital
Henan, Zhengzhou, 450003
- Not yet recruiting
The Second People's Hospital of Zhengzhou
Henan, Zhengzhou, 450015
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450052
- Not yet recruiting
Huanggang Central Hospital
Hubei, Huanggang, 438000
- Not yet recruiting
Jingzhou First People's Hospital
Hubei, Jingzhou, 434000
- Not yet recruiting
Taihe Hospital, Shiyan
Hubei, Shiyan, 442000
- Not yet recruiting
Renmin Hospital of Wuhan University
Hubei, Wuhan, 430060
- Not yet recruiting
Wuhan Third Hospital (Wuhan Tongren Hospital)
Hubei, Wuhan, 430060
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Hubei, Wuhan, 430077
- Not yet recruiting
Changde First People's Hospital
Hunan, Changde, 415000
- Not yet recruiting
The Third Hospital of Changsha
Hunan, Changsha, 410000
- Not yet recruiting
Changsha Central Hospital
Hunan, Changsha, 410004
- Not yet recruiting
Xiangya Hospital of Central South University
Hunan, Changsha, 410008
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Hunan, Changsha, 410011
- Not yet recruiting
The Third Xiangya Hospital of Central South University
Hunan, Changsha, 410013
- Not yet recruiting
Shaoyang Central Hospital
Hunan, Shaoyang, 422000
- Not yet recruiting
Zhuzhou Central Hospital
Hunan, Zhuzhou, 412007
- Not yet recruiting
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Inner Mongolia, Baotou, 014010
- Not yet recruiting
Inner Mongolia Autonomous Region People's Hospital
Inner Mongolia, Hohhot, 010017
- Not yet recruiting
The Second People's Hospital of Lianyungang
Jiangsu, Lianyungang, 222023
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Jiangsu, Nanjing, 210011
- Not yet recruiting
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Jiangsu, Nanjing, 210029
- Not yet recruiting
Nanjing Brain Hospital
Jiangsu, Nanjing, 210029
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215004
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215006
- Not yet recruiting
Wuxi People's Hospital
Jiangsu, Wuxi, 214023
- Not yet recruiting
The Second Hospital of Jilin University
Jilin City, Changchun, 130022
- Not yet recruiting
Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology
Liaoning, Dalian, 116033
- Not yet recruiting
General Hospital of Northern Theater Command of Chinese PLA
Liaoning, Shenyang, 110016
- Not yet recruiting
The People's Hospital of Liaoning Province
Liaoning, Shenyang, 110016
- Not yet recruiting
The First People's Hospital of Yinchuan
Ningxia, Yinchuan, 750001
- Not yet recruiting
Qilu Hospital of Shandong University
Shandong, Jinan, 250012
- Not yet recruiting
Jinan Central Hospital
Shandong, Jinan, 250013
- Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Shandong, Jinan, 250014
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Shandong, Jining, 272029
- Not yet recruiting
Liaocheng People's Hospital
Shandong, Liaocheng, 252000
- Not yet recruiting
Qingdao Central Hospital
Shandong, Qingdao, 266042
- Not yet recruiting
Rizhao People's Hospital of Shandong Province
Shandong, Rizhao, 276800
- Not yet recruiting
Zaozhuang Municipal Hospital
Shandong, Zaozhuang, 277102
- Not yet recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
- Not yet recruiting
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434
- Not yet recruiting
Baoji Central Hospital
Shanxi, Baoji, 721008
- Not yet recruiting
Shaanxi Provincial People's Hospital
Shanxi, Xi'an, 710068
- Not yet recruiting
Xi'an Gaoxin Hospital
Shanxi, Xi'an, 710075
- Not yet recruiting
The First Affiliated Hospital of Xi'an Medical University
Shanxi, Xi'an, 710077
- Not yet recruiting
Xianyang Hospital of Yan'an University
Shanxi, Xianyang, 712000
- Not yet recruiting
Dazhou Central Hospital
Sichuan, Dazhou, 635000
- Not yet recruiting
The First People's Hospital of Zigong
Sichuan, Zigong, 643000
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
- Not yet recruiting
The Second Affiliated Hospital of Xinjiang Medical University
Xinjiang, Urumqi, 830017
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650032
- Not yet recruiting
The Second Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650033
- Not yet recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310009
- Not yet recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310016
- Not yet recruiting
Huzhou Central Hospital
Zhejiang, Huzhou, 313000
- Not yet recruiting
Rui'an People's Hospital
Zhejiang, Ruian, 325200
About this study
Official title: 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
- Conditions
- Migraine, With or Without Aura
- Being tested
- BR005-036C, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR005-036CDrug
Dose 1, Oral tablet
BR005-036CDrug
Dose 2, Oral tablet
PlaceboDrug
Placebo tablet to match BR005-036C dose, Oral
| Study group | Role | What they receive |
|---|---|---|
| BR005-036C Dose 1 | Experimental | Not described Receives: Drug: BR005-036C |
| BR005-036C Dose 2 | Experimental | Not described Receives: Drug: BR005-036C |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Freedom from Pain at 2 hours post-dose
Measured: 2 hours post-dose
Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose
Measured: 2 hours post-dose
Secondary outcomes (6)
Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose
Measured: From 2 hours up to 24 hours post-dose
Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose
Measured: From 2 hours up to 48 hours post-dose
Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose
Measured: From 2 hours up to 24 hours post-dose
Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose
Measured: 2 hours post-dose
Percentage of Participants with Pain Relief at 2 hours post-dose
Measured: 2 hours post-dose
Number of Participants With Adverse Events (AEs)
Measured: On-treatment period was from the administration of study intervention and through the EOT visit, up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start30 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine, With or Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,079 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brise Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792681
- Sponsor's protocol ID
- BR005-301
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No