The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,079
Dose 1, Oral tablet
Dose 2, Oral tablet
Placebo tablet to match BR005-036C dose, Oral
Percentage of Participants with Freedom from Pain at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of Participants with Sustained Pain Freedom from 2 to 24 hours post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants with Sustained Pain Freedom from 2 to 48 hours post-dose
Time frame: From 2 hours up to 48 hours post-dose
Percentage of Participants with Rescue Medication Use from 2 to 24 hours post-dose
Time frame: From 2 hours up to 24 hours post-dose
Percentage of Participants with Freedom from Functional Disability at 2 hours post-dose
Time frame: 2 hours post-dose
Percentage of Participants with Pain Relief at 2 hours post-dose
Time frame: 2 hours post-dose
Number of Participants With Adverse Events (AEs)
Time frame: On-treatment period was from the administration of study intervention and through the EOT visit, up to 9 days
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Peking University People's Hospital
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Peking University Third Hospital
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First Medical Center of Chinese PLA General Hospital
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Cangzhou Central Hospital
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...and 73 more locations