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Migraine, With or Without AuraPhase 3NCT07835152

Long-term Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults

A Phase 3 study testing BR005-036C in people with Migraine, With or Without Aura, run by Brise Pharmaceuticals Co., Ltd. at 81 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of 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?
No, everyone receives an active treatment
How many people
1,000 participants
Where
81 sitesChina
Study dates
30 Sep 2026to 30 Apr 2029
Phase
Phase 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.
  • At least 2 migraine attacks need to treat 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

81 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

81 sites in 1 country

China81 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Anhui, Bengbu, 233004

  • The Second People's Hospital of Hefei

    Anhui, Hefei, 230011

  • The Second Affiliated Hospital of Anhui Medical University

    Anhui, Hefei, 230601

  • Xuancheng People's Hospital

    Anhui, Xuancheng, 242000

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

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

    Beijing, Beijing Municipality, 100730

  • First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

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

    Chongqing, Chongqing Municipality, 400014

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Chonggang General Hospital

    Chongqing, Chongqing Municipality, 400084

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Xiamen University

    Fujian, Xiamen, 361003

  • The Second Hospital of Lanzhou University

    Gansu, Lanzhou, 730030

  • The 940th Hospital of PLA Joint Logistic Support Force

    Gansu, Lanzhou, 730050

  • Guangdong Provincial People's Hospital

    Guangdong, Guangzhou, 510080

  • Guangzhou First People's Hospital

    Guangdong, Guangzhou, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangdong, Guangzhou, 510260

  • Shenzhen People's Hospital

    Guangdong, Shenzhen, 518020

  • Shenzhen Second People's Hospital

    Guangdong, Shenzhen, 518035

  • Cangzhou Central Hospital

    Hebei, Cangzhou, 061001

  • Hebei General Hospital

    Hebei, Shijiazhuang, 050051

  • The Fourth Affiliated Hospital of Harbin Medical University

    Heilongjiang, Harbin, 150001

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

    Henan, Luoyang, 471003

  • The First Affiliated Hospital of Nanyang Medical College

    Henan, Nanyang, 473058

  • Zhengzhou People's Hospital

    Henan, Zhengzhou, 450003

  • The Second People's Hospital of Zhengzhou

    Henan, Zhengzhou, 450015

  • The First Affiliated Hospital of Zhengzhou University

    Henan, Zhengzhou, 450052

  • Huanggang Central Hospital

    Hubei, Huanggang, 438000

  • Jingzhou First People's Hospital

    Hubei, Jingzhou, 434000

  • Taihe Hospital, Shiyan

    Hubei, Shiyan, 442000

  • Renmin Hospital of Wuhan University

    Hubei, Wuhan, 430060

  • Wuhan Third Hospital (Wuhan Tongren Hospital)

    Hubei, Wuhan, 430060

  • Zhongnan Hospital of Wuhan University

    Hubei, Wuhan, 430077

  • The First People's Hospital of Changde

    Hunan, Changde, 415003

  • The Third Hospital of Changsha

    Hunan, Changsha, 410000

  • Changsha Central Hospital

    Hunan, Changsha, 410004

  • Xiangya Hospital of Central South University

    Hunan, Changsha, 410008

  • The Second Xiangya Hospital of Central South University

    Hunan, Changsha, 410011

  • The Third Xiangya Hospital of Central South University

    Hunan, Changsha, 410013

  • Shaoyang Central Hospital

    Hunan, Shaoyang, 422000

  • Zhuzhou Central Hospital

    Hunan, Zhuzhou, 412007

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Inner Mongolia, Baotou, 014010

  • Inner Mongolia Autonomous Region People's Hospital

    Inner Mongolia, Hohhot, 010017

  • The Second People's Hospital of Lianyungang

    Jiangsu, Lianyungang, 222023

  • The Second Affiliated Hospital of Nanjing Medical University

    Jiangsu, Nanjing, 210011

  • Nanjing Brain Hospital

    Jiangsu, Nanjing, 210029

  • The Second Affiliated Hospital of Soochow University

    Jiangsu, Suzhou, 215004

  • The First Affiliated Hospital of Soochow University

    Jiangsu, Suzhou, 215006

  • Wuxi People's Hospital

    Jiangsu, Wuxi, 214023

  • The Second Hospital of Jilin University

    Jilin City, Changchun, 130022

  • Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology

    Liaoning, Dalian, 116033

  • General Hospital of Northern Theater Command of Chinese PLA

    Liaoning, Shenyang, 110016

  • The People's Hospital of Liaoning Province

    Liaoning, Shenyang, 110016

  • The First People's Hospital of Yinchuan

    Ningxia, Yinchuan, 750001

  • Jinan Central Hospital

    Shandong, Jinan, 250013

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

    Shandong, Jinan, 250014

  • Affiliated Hospital of Jining Medical University

    Shandong, Jining, 272029

  • Liaocheng People's Hospital

    Shandong, Liaocheng, 252000

  • Qilu Hospital of Shandong University

    Shandong, Qilu, 250012

  • Qingdao Central Hospital

    Shandong, Qingdao, 266042

  • Rizhao People's Hospital of Shandong Province

    Shandong, Rizhao, 276800

  • Zaozhuang Municipal Hospital

    Shandong, Zaozhuang, 277102

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Fourth People's Hospital

    Shanghai, Shanghai Municipality, 200434

  • Baoji Central Hospital

    Shanxi, Baoji, 721008

  • Shaanxi Provincial People's Hospital

    Shanxi, Xi'an, 710068

  • Xi'an Gaoxin Hospital

    Shanxi, Xi'an, 710075

  • The First Affiliated Hospital of Xi'an Medical University

    Shanxi, Xi'an, 710077

  • Xianyang Hospital of Yan'an University

    Shanxi, Xianyang, 712000

  • Dazhou Central Hospital

    Sichuan, Dazhou, 635000

  • The First People's Hospital of Zigong

    Sichuan, Zigong, 643000

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

  • The Second Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Urumqi, 830017

  • The Second Affiliated Hospital of Kunming Medical University

    Yunnan, Kunming, 650101

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Zhejiang, Hangzhou, 310009

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Zhejiang, Hangzhou, 310016

  • Rui'an People's Hospital

    Zhejiang, Ruian, 325200

  • Huzhou Central Hospital

    Zhengjiang, Huzhou, 313000

Other trials in China

About this study

Official title: A Multiple Center, Open-label Phase III Study to Evaluate Long-term Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults

The purpose of this study is to evaluate the long-term safety of BR005-036C tablets in the acute treatment of migraines

Being tested
BR005-036C
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, PRN

Study groups in NCT07835152
Study groupRoleWhat they receive
BR005-036CExperimentalNot described
Receives: Drug: BR005-036C

What is being measured

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

  1. Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period.

    Measured: Up to 52 weeks

Secondary outcomes (3)

  1. Percentage of participants with Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) concurrent with Total Bilirubin > 2 x ULN during the treatment period

    Measured: Up to 52 weeks

  2. Number of participants with hepatic functional abnormal during the treatment period

    Measured: Up to 52 weeks

  3. Percentage of participants stratified by satisfaction level after BR005-036C treatment

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion30 Apr 2029 (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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07835152
Sponsor's protocol ID
BR005-302
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
25 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BR005-036C in people with Migraine, With or Without Aura, run by Brise Pharmaceuticals Co., Ltd. at 81 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 5 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Number of participants with ≥5% AEs，SAEs, and AEs leading to discontinuation and clinically significant laboratory abnormalities during the treatment period. (time frame: Up to 52 weeks). 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 NCT07835152.

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 25 Sep 2026.

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