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

NCT ID: NCT07835152
Registry status: Not yet recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Brise Pharmaceuticals Co., Ltd.
Conditions: Migraine, With or Without Aura

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 1000 participants (Estimated).

What is being studied

Drug: BR005-036C

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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. At least 2 migraine attacks need to treat per month within 3 months prior to screening visit. 4. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit. 5. 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).

Study locations

81 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: China

Baoji, China: 1
Baotou, China: 1
Beijing Municipality, China: 6
Bengbu, China: 1
Cangzhou, China: 1
Changchun, China: 1
Changde, China: 1
Changsha, China: 5
Chongqing Municipality, China: 4
Dalian, China: 1
Dazhou, China: 1
Guangzhou, China: 3
Hangzhou, China: 2
Harbin, China: 1
Hefei, China: 2
Hohhot, China: 1
Huanggang, China: 1
Huzhou, China: 1
Jinan, China: 2
Jingzhou, China: 1
Jining, China: 1
Kunming, China: 1
Lanzhou, China: 2
Lianyungang, China: 1
Liaocheng, China: 1
Luoyang, China: 1
Nanjing, China: 2
Nanyang, China: 1
Qilu, China: 1
Qingdao, China: 1

Sample of listed locations

Baoji Central Hospital — Shanxi, Baoji, 721008, China — Site recruitment status not specified in the registry data
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology — Inner Mongolia, Baotou, 014010, China — Site recruitment status not specified in the registry data
Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, 100050, China — Site recruitment status not specified in the registry data
First Medical Center of Chinese PLA General Hospital — Beijing, Beijing Municipality, 100853, China — Site recruitment status not specified in the registry data
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, 100730, China — Site recruitment status not specified in the registry data
Peking University People's Hospital — Beijing, Beijing Municipality, 100044, China — Site recruitment status not specified in the registry data
Peking University Third Hospital — Beijing, Beijing Municipality, 100191, China — Site recruitment status not specified in the registry data
Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, 100053, China — Site recruitment status not specified in the registry data
The First Affiliated Hospital of Bengbu Medical College — Anhui, Bengbu, 233004, China — Site recruitment status not specified in the registry data
Cangzhou Central Hospital — Hebei, Cangzhou, 061001, China — Site recruitment status not specified in the registry data
The Second Hospital of Jilin University — Jilin City, Changchun, 130022, China — Site recruitment status not specified in the registry data
The First People's Hospital of Changde — Hunan, Changde, 415003, China — Site recruitment status not specified in the registry data
Changsha Central Hospital — Hunan, Changsha, 410004, China — Site recruitment status not specified in the registry data
The Second Xiangya Hospital of Central South University — Hunan, Changsha, 410011, China — Site recruitment status not specified in the registry data
The Third Hospital of Changsha — Hunan, Changsha, 410000, China — Site recruitment status not specified in the registry data
The Third Xiangya Hospital of Central South University — Hunan, Changsha, 410013, China — Site recruitment status not specified in the registry data
Xiangya Hospital of Central South University — Hunan, Changsha, 410008, China — Site recruitment status not specified in the registry data
Chonggang General Hospital — Chongqing, Chongqing Municipality, 400084, China — Site recruitment status not specified in the registry data
Chongqing University Three Gorges Hospital — Chongqing, Chongqing Municipality, 404000, China — Site recruitment status not specified in the registry data
The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, 400016, China — Site recruitment status not specified in the registry data
The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center) — Chongqing, Chongqing Municipality, 400014, China — Site recruitment status not specified in the registry data
Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology — Liaoning, Dalian, 116033, China — Site recruitment status not specified in the registry data
Dazhou Central Hospital — Sichuan, Dazhou, 635000, China — Site recruitment status not specified in the registry data
Guangdong Provincial People's Hospital — Guangdong, Guangzhou, 510080, China — Site recruitment status not specified in the registry data
Guangzhou First People's Hospital — Guangdong, Guangzhou, 510180, China — Site recruitment status not specified in the registry data

Study details

Start date: September 30, 2026
Primary completion date: March 31, 2029
Completion date: April 30, 2029
First posted: September 22, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07835152
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT07835152 on ClinicalTrials.gov

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