Migraine, With or Without Aura
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines
Interventions
DRUGBR005-036C
Dose 1, Oral tablet
DRUGPlacebo
Placebo tablet to match BR005-036C dose, Oral
Sponsors
Brise Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 × 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Freedom from Pain at 2 hours post-dose | 2 hours post-dose |
| Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose | 2 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose | From 2 hours up to 24 hours post-dose |
| Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose | From 2 hours up to 48 hours post-dose |
| Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose | From 2 hours up to 24 hours post-dose |
| Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose | 2 hours post-dose |
| Percentage of Participants with Pain Relief at 2 hours post-dose | 2 hours post-dose |
| Number of Participants With Adverse Events (AEs) | On-treatment period was from the administration of study intervention and through the EOT visit, up to 9 days |
Countries
China
Contacts
CONTACTBrise Pharmaceuticals Co., Ltd.
Outcome results
None listed