This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
330
Orally administered EVO756, Dose 1 (Daily)
Orally administered EVO756, Dose 2 (Daily)
Placebo Control (Daily)
Mean change from baseline in the number of monthly migraine days (MMD)
Time frame: Last month of the 12-week treatment period
Mean change from baseline in the number of MMD
Time frame: Weeks 4, 8, and across the treatment period (up to 12-weeks)
Mean change from baseline in the number of monthly headache days (MHD)
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MMD
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Proportion of subjects achieving ≥50% and ≥75% reduction in MHD
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Mean change from baseline in monthly acute migraine medication use days
Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)
Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame: through Week 16
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