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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.
Show all 10Show fewer
  • 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.

Brise Pharmaceuticals Co., Ltd. contact

+81-21-80517689

ra@brisepharma.com

83 sites in 1 country

China83 sites, 83 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

    Not yet recruiting

  • First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    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

    Not yet recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Jiangsu, Nanjing, 210011

    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

    Not yet recruiting

Other trials in China

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

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 groups in NCT07792681
Study groupRoleWhat they receive
BR005-036C Dose 1ExperimentalNot described
Receives: Drug: BR005-036C
BR005-036C Dose 2ExperimentalNot described
Receives: Drug: BR005-036C
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Freedom from Pain at 2 hours post-dose

    Measured: 2 hours post-dose

  2. Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose

    Measured: 2 hours post-dose

Secondary outcomes (6)

  1. Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose

    Measured: From 2 hours up to 24 hours post-dose

  2. Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose

    Measured: From 2 hours up to 48 hours post-dose

  3. Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose

    Measured: From 2 hours up to 24 hours post-dose

  4. Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose

    Measured: 2 hours post-dose

  5. Percentage of Participants with Pain Relief at 2 hours post-dose

    Measured: 2 hours post-dose

  6. 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.

  1. First posted28 Aug 2026
  2. Study start30 Sep 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brise Pharmaceuticals Co., Ltd. (+81-21-80517689, ra@brisepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Freedom from Pain at 2 hours post-dose (time frame: 2 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07792681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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