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โ† Trials
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Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllBrise Pharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ร— upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 mยฒ. 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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What it tests

  • BR005-036C
  • BR005-036C
  • Placebo
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Where

83 sites
Baoji Central Hospital
Shanxi, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Inner Mongolia, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
First Medical Center of Chinese PLA General Hospital
Beijing, China

โ€ฆand 75 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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