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Can a new pill stop migraine pain within two hours?

NCT ID NCT07792681

Symptom relief Sponsor: Brise Pharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 2,079 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

migraine disorder migraine without aura

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine, with or without aura

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    78 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Affiliated Hospital of Jiangnan University

    Jiangsu, Wuxi, 214062, China

  • Affiliated Hospital of Jining Medical University

    Shandong, Jining, 272029, 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

  • Cangzhou Central Hospital

    Hebei, Cangzhou, 061001, China

  • Changsha Central Hospital

    Hunan, Changsha, 410004, China

  • Dazhou Central Hospital

    Sichuan, Dazhou, 635000, China

  • First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Fujian Medical University Union Hospital

    Fujian, Fuzhou, 350001, China

  • General Hospital of Ningxia Medical University

    Ningxia, Yinchuan, 750004, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

  • Guangzhou First People's Hospital

    Guangdong, Guangzhou, 510180, China

  • Hainan General Hospital

    Hainan, Haikou, 570311, China

  • Hebei General Hospital

    Hebei, Shijiazhuang, 050051, China

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    Jiangsu, Nanjing, 210029, China

  • Jinan Central Hospital

    Shandong, Jinan, 250013, China

  • Jingzhou Central Hospital

    Hubei, Jingzhou, 434020, 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

  • Nanjing Brain Hospital

    Jiangsu, Nanjing, 210029, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191, China

  • Pingxiang People's Hospital

    Jiangxi, Pingxiang, 337055, China

  • Qingdao Central Hospital

    Shandong, Qingdao, 266042, China

  • Renmin Hospital of Wuhan University

    Hubei, Wuhan, 430060, China

  • Shanghai Fourth People's Hospital

    Shanghai, Shanghai Municipality, 200434, China

  • Shanxi Provincial Cardiovascular Hospital

    Shanxi, Taiyuan, 030024, China

  • Shaoyang Central Hospital

    Hunan, Shaoyang, 422000, China

  • Sinopharm Dongfeng General Hospital

    Hubei, Shiyan, 442008, China

  • The 940th Hospital of PLA Joint Logistic Support Force

    Gansu, Lanzhou, 730050, China

  • The Affiliated Hospital of Guizhou Medical University

    Guizhou, Guiyang, 550004, China

  • The Affiliated Hospital of Qingdao University

    Shandong, Qingdao, 266003, China

  • The First Affiliated Hospital of Bengbu Medical College

    Anhui, Bengbu, 233004, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Dalian Medical University

    Liaoning, Dalian, 116011, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Henan, Luoyang, 471003, China

  • The First Affiliated Hospital of Nanyang Medical College

    Henan, Nanyang, 473058, China

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

    Shandong, Jinan, 250014, China

  • The First Affiliated Hospital of Soochow University

    Jiangsu, Suzhou, 215006, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangdong, Guangzhou, 510080, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Shanxi, Xi'an, 710061, 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

  • The First Hospital of Jilin University

    Jilin City, Changchun, 130021, China

  • The First People's Hospital of Changde

    Hunan, Changde, 415003, China

  • The First People's Hospital of Jingzhou

    Hubei, Jingzhou, 434000, China

  • The First People's Hospital of Yinchuan

    Ningxia, Yinchuan, 750001, China

  • The First People's Hospital of Zigong

    Sichuan, Zigong, 643000, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    Heilongjiang, Harbin, 150001, China

  • The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)

    Chongqing, Chongqing Municipality, 400014, China

  • The People's Hospital of Liaoning Province

    Liaoning, Shenyang, 110016, China

  • The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital)

    Shanxi, Xi'an, 710038, China

  • The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

    Chongqing, Chongqing Municipality, 400037, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangdong, Guangzhou, 510260, China

  • The Second Affiliated Hospital of Kunming Medical University

    Yunnan, Kunming, 650101, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Jiangsu, Nanjing, 210011, China

  • The Second Affiliated Hospital of Qiqihar Medical University

    Heilongjiang, Qiqihar, 161006, China

  • The Second Affiliated Hospital of Soochow University

    Jiangsu, Suzhou, 215004, China

  • The Second Central Hospital of Baoding

    Hebei, Baoding, 072750, China

  • The Second Hospital of Hebei Medical University

    Hebei, Shijiazhuang, 050000, China

  • The Second People's Hospital of Hefei

    Anhui, Hefei, 230011, China

  • The Second People's Hospital of Lianyungang

    Jiangsu, Lianyungang, 222023, 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 University of Hong Kong-Shenzhen Hospital

    Guangdong, Shenzhen, 518053, China

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121, China

  • Wenzhou People's Hospital

    Zhejiang, Wenzhou, 325000, China

  • Wuhan Third Hospital (Wuhan Tongren Hospital)

    Hubei, Wuhan, 430060, China

  • Xi'an Gaoxin Hospital

    Shanxi, Xi'an, 710075, China

  • Xiangya Hospital of Central South University

    Hunan, Changsha, 410008, China

  • Xianyang Hospital of Yan'an University

    Shanxi, Xianyang, 712000, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • Zaozhuang Municipal Hospital

    Shandong, Zaozhuang, 277102, China

  • Zhengzhou People's Hospital

    Henan, Zhengzhou, 450003, China

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