Can a new pill stop migraine pain within two hours?
NCT ID NCT07792681
First seen Aug 28, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This trial tests whether an experimental oral drug called BR005-036C can quickly relieve migraine attacks in adults. Researchers will compare two doses of the drug against a placebo in about 2,079 people who have migraines with or without aura. The main goals are to see if the drug frees participants from pain and from their most bothersome symptom within two hours of taking it. The study also checks how long relief lasts and whether the drug is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BR005-036C, an oral tablet taken during a migraine attack
- What this could lead to
- If it works, BR005-036C could offer a new fast-acting option for people with migraine, easing pain and associated symptoms within two hours.
- What could go wrong
- This is a mid-stage trial, so the drug may not prove more effective than placebo. As with any migraine medication, side effects are possible, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 2,079 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female Participants aged 18 years or older. 2. 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. 3. Onset age of migraine shall be less than 50 years old. 4. At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit. 5. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit. 6. 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 Criteria: 1. 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. 2. 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. 3. 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. 4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening. 5. Abnormal electrocardiogram findings at screening: QTcF \>450 msec for male subjects; QTcF \>470 msec for female subjects. 6. Patient with uncontrolled hypertension. 7. History of alcohol or substance abuse within 6 months prior to screening. 8. 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. 9. 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. 10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
83 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Jining Medical University
Shandong, Jining, 272029, China
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Baoji Central Hospital
Shanxi, Baoji, 721008, China
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
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Cangzhou Central Hospital
Hebei, Cangzhou, 061001, China
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Changde First People's Hospital
Hunan, Changde, 415000, China
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Changsha Central Hospital
Hunan, Changsha, 410004, China
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Chonggang General Hospital
Chongqing, Chongqing Municipality, 400084, China
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Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
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Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology
Liaoning, Dalian, 116033, China
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Dazhou Central Hospital
Sichuan, Dazhou, 635000, China
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First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
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General Hospital of Northern Theater Command of Chinese PLA
Liaoning, Shenyang, 110016, China
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
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Guangzhou First People's Hospital
Guangdong, Guangzhou, 510180, China
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Hebei General Hospital
Hebei, Shijiazhuang, 050051, China
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Huanggang Central Hospital
Hubei, Huanggang, 438000, China
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Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
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Huzhou Central Hospital
Zhejiang, Huzhou, 313000, China
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Inner Mongolia Autonomous Region People's Hospital
Inner Mongolia, Hohhot, 010017, China
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Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Jiangsu, Nanjing, 210029, China
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Jinan Central Hospital
Shandong, Jinan, 250013, China
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Jingzhou First People's Hospital
Hubei, Jingzhou, 434000, China
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Liaocheng People's Hospital
Shandong, Liaocheng, 252000, China
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Nanjing Brain Hospital
Jiangsu, Nanjing, 210029, China
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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Qilu Hospital of Shandong University
Shandong, Jinan, 250012, China
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Qingdao Central Hospital
Shandong, Qingdao, 266042, China
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Renmin Hospital of Wuhan University
Hubei, Wuhan, 430060, China
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Rizhao People's Hospital of Shandong Province
Shandong, Rizhao, 276800, China
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Rui'an People's Hospital
Zhejiang, Ruian, 325200, China
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Shaanxi Provincial People's Hospital
Shanxi, Xi'an, 710068, China
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Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200434, China
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Shaoyang Central Hospital
Hunan, Shaoyang, 422000, China
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Shenzhen People's Hospital
Guangdong, Shenzhen, 518020, China
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Shenzhen Second People's Hospital
Guangdong, Shenzhen, 518035, China
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310016, China
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Taihe Hospital, Shiyan
Hubei, Shiyan, 442000, China
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The 940th Hospital of PLA Joint Logistic Support Force
Gansu, Lanzhou, 730050, China
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The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Inner Mongolia, Baotou, 014010, China
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The First Affiliated Hospital of Bengbu Medical College
Anhui, Bengbu, 233004, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
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The First Affiliated Hospital of Henan University of Science and Technology
Henan, Luoyang, 471003, China
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The First Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650032, China
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The First Affiliated Hospital of Nanyang Medical College
Henan, Nanyang, 473058, China
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The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Shandong, Jinan, 250014, China
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The First Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215006, China
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The First Affiliated Hospital of Xi'an Medical University
Shanxi, Xi'an, 710077, China
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The First Affiliated Hospital of Xiamen University
Fujian, Xiamen, 361003, China
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The First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450052, China
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The First People's Hospital of Yinchuan
Ningxia, Yinchuan, 750001, China
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The First People's Hospital of Zigong
Sichuan, Zigong, 643000, China
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The Fourth Affiliated Hospital of Harbin Medical University
Heilongjiang, Harbin, 150001, China
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The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)
Chongqing, Chongqing Municipality, 400014, China
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The People's Hospital of Liaoning Province
Liaoning, Shenyang, 110016, China
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The Second Affiliated Hospital of Anhui Medical University
Anhui, Hefei, 230601, China
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The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510260, China
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The Second Affiliated Hospital of Kunming Medical University
Yunnan, Kunming, 650033, China
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The Second Affiliated Hospital of Nanjing Medical University
Jiangsu, Nanjing, 210011, China
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The Second Affiliated Hospital of Soochow University
Jiangsu, Suzhou, 215004, China
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The Second Affiliated Hospital of Xinjiang Medical University
Xinjiang, Urumqi, 830017, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310009, China
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The Second Hospital of Jilin University
Jilin City, Changchun, 130022, China
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The Second Hospital of Lanzhou University
Gansu, Lanzhou, 730030, China
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The Second People's Hospital of Hefei
Anhui, Hefei, 230011, China
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The Second People's Hospital of Lianyungang
Jiangsu, Lianyungang, 222023, China
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The Second People's Hospital of Zhengzhou
Henan, Zhengzhou, 450015, China
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The Second Xiangya Hospital of Central South University
Hunan, Changsha, 410011, China
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The Third Hospital of Changsha
Hunan, Changsha, 410000, China
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The Third Xiangya Hospital of Central South University
Hunan, Changsha, 410013, China
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Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
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Wuhan Third Hospital (Wuhan Tongren Hospital)
Hubei, Wuhan, 430060, China
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Wuxi People's Hospital
Jiangsu, Wuxi, 214023, China
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Xi'an Gaoxin Hospital
Shanxi, Xi'an, 710075, China
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Xiangya Hospital of Central South University
Hunan, Changsha, 410008, China
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Xianyang Hospital of Yan'an University
Shanxi, Xianyang, 712000, China
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Xuancheng People's Hospital
Anhui, Xuancheng, 242000, China
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
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Zaozhuang Municipal Hospital
Shandong, Zaozhuang, 277102, China
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Zhengzhou People's Hospital
Henan, Zhengzhou, 450003, China
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Zhongnan Hospital of Wuhan University
Hubei, Wuhan, 430077, China
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Zhuzhou Central Hospital
Hunan, Zhuzhou, 412007, China
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