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Még nem keres résztvevőt itt: Kína3. fázis

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

A legfontosabb adatok

Ki végzi
Brise Pharmaceuticals Co., Ltd.
Hol
Anhui, Beijing, Chongqing, Fujian, Gansu, Guangdong, Hebei, Heilongjiang, Henan, Hubei, Hunan, Inner Mongolia, Jiangsu, Jilin City, Liaoning, Ningxia, Shandong, Shanghai, Shanxi, Sichuan, Tianjin, Xinjiang, Yunnan, Zhejiang és Zhengjiang (Kína)Mind a 79 helyszín megnézése
Azonosító
Állapot
Toborzás még nem indult
Fázis
3. fázis
Résztvevők
1000 fő, tervezett
Kezdés
2026. nov. 20.
Várható befejezés
2029. ápr. 30.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • BR005-036C
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akik aurával vagy aura nélkül migrénben szenvednek, és a BR005-036C tabletta hosszú távú biztonságosságát vizsgálja migrénrohamok kezelésére.

Életkor
18 éves vagy idősebb.
Nem
Férfiak és nők is részt vehetnek.
A betegség stádiuma
Legalább 1 éve fennálló migrén aurával vagy aura nélkül. A szűrés előtti 3 hónapban havonta legalább 2 kezelést igénylő roham. Havonta kevesebb mint 15 fejfájásos nap.
Korábbi kezelés
Migrén elleni megelőző gyógyszer szedhető, ha az adag legalább 3 hónapja stabil. A szűrés vagy a randomizálás előtt 1 hónapon belül nem kaphattál CGRP-receptor-antagonistát. A szűrés vagy a randomizálás előtt 6 hónapon belül nem kaphattál anti-CGRP vagy anti-CGRP-receptor ellenanyagot. A randomizálás előtti 3 hónapban havonta legfeljebb 10 napon szedhettél rohamkezelő migrénszert.

A részvétel fő kizáró okai

  • Más típusú fejfájás, például hemiplegiás, retinális vagy agytörzsi aurás migrén, vagy cluster típusú fejfájások
  • Súlyos szív-, agyi, máj-, vese- vagy más betegség, illetve egyéb krónikus fájdalom
  • Májbetegség, vagy heveny hepatitis a szűrés előtti 6 hónapban
  • Daganatos betegség a szűrés előtti 5 évben
  • Nem kezelt magas vérnyomás vagy kóros EKG-lelet a szűréskor

A regiszter feltételei, szó szerint

Mind a 15 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • History of alcohol or substance abuse within 6 months prior to screening
  • 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)
  • 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 uncontrolled hypertension
  • 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
  • Abnormal electrocardiogram findings at screening: QTcF >450 msec for male subjects; QTcF >470 msec for female subjects

Helyszínek itt: Kína

  • the First Affiliated Hospital of Bengbu Medical CollegeAnhui, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital of Anhui Medical UniversityAnhui, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second People's Hospital of HefeiAnhui, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Xuancheng People's HospitalAnhui, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • First Medical Center of Chinese PLA General HospitalBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Peking University People's HospitalBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Peking University Third HospitalBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Xuanwu Hospital, Capital Medical UniversityBeijing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Chonggang General HospitalChongqing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Chongqing University Three Gorges HospitalChongqing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)Chongqing, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Xiamen UniversityFujian, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The 940th Hospital of PLA Joint Logistic Support ForceGansu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Hospital of Lanzhou UniversityGansu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Guangdong Provincial People'S HospitalGuangdong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Guangzhou First People's HospitalGuangdong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Shenzhen People's HospitalGuangdong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Shenzhen Second People's HospitalGuangdong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital of Guangzhou Medical UniversityGuangdong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Cangzhou Central HospitalHebei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Hebei General HospitalHebei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Fourth Affiliated Hospital of Harbin Medical UniversityHeilongjiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Henan University of Science and TechnologyHenan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Nanyang Medical CollegeHenan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second People's Hospital of ZhengzhouHenan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Zhengzhou People's HospitalHenan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Huanggang Central HospitalHubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Jingzhou First People's HospitalHubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Renmin Hospital of Wuhan UniversityHubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Taihe Hospital, ShiyanHubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Wuhan Third Hospital (Wuhan Tongren Hospital)Hubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Zhongnan Hospital of Wuhan UniversityHubei, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Changsha Central HospitalHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Shaoyang Central HospitalHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First People's Hospital of ChangdeHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Xiangya Hospital of Central South UniversityHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Third Hospital of ChangshaHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Third Xiangya Hospital of Central South UniversityHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Xiangya Hospital of Central South UniversityHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Zhuzhou Central HospitalHunan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyInner Mongolia, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Nanjing Brain HospitalJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Soochow UniversityJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital of Nanjing Medical UniversityJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital of Soochow UniversityJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second People's Hospital of LianyungangJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Wuxi People's HospitalJiangsu, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Hospital of Jilin UniversityJilin City, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Dalian Municipal Central Hospital, Affiliated to Dalian University of TechnologyLiaoning, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • General Hospital of Northern Theater Command of Chinese PLALiaoning, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The People's Hospital of Liaoning ProvinceLiaoning, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First People's Hospital of YinchuanNingxia, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Affiliated Hospital of Jining Medical UniversityShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Jinan Central HospitalShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Liaocheng People's HospitalShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Qilu Hospital of Shandong UniversityShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Qingdao Central HospitalShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Rizhao People's Hospital of Shandong ProvinceShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)Shandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Zaozhuang Municipal HospitalShandong, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Huashan Hospital, Fudan UniversityShanghai, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Shanghai Fourth People's HospitalShanghai, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Baoji Central HospitalShanxi, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Shaanxi Provincial People's HospitalShanxi, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First Affiliated Hospital of Xi'an Medical UniversityShanxi, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Xi'an Gaoxin HospitalShanxi, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Xianyang Hospital of Yan'an UniversityShanxi, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Dazhou Central HospitalSichuan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The First People's Hospital of ZigongSichuan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Tianjin People's HospitalTianjin, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital of Xinjiang Medical UniversityXinjiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The second affiliated hospital of Kunming medical universityYunnan, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Rui'an People's HospitalZhejiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Sir Run Run Shaw Hospital Zhejiang University School of MedicineZhejiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • The Second Affiliated Hospital Zhejiang University School of MedicineZhejiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part
  • Huzhou Central HospitalZhengjiang, KínaContact: Brise Pharmaceuticals Co., Ltd.No longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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

A vizsgálat csoportja

  • BR005-036CA vizsgált kezelés

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
A regiszteradat frissítve
2026. november 12.