This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
134
Single oral dose of matching placebo
Single oral dose of K-645 dose level 1
Single oral dose of K-645 dose level 2
Excell Research, Inc.
Oceanside, California, United States
DelRicht Research - Atlanta
Atlanta, Georgia, United States
Percentage of participants with pain freedom
Time frame: 2 hours post-dose
Percentage of participants with freedom from the most bothersome symptom
Time frame: 2 hours post-dose
Percentage of participants who report pain relief
Time frame: 2 hours post-dose
Percentage of participants who experienced 1 or more treatment-emergent adverse events (AEs)
Time frame: up to 7 days after the last dose of study medication
Percentage of participants who experienced 1 or more treatment-emergent serious adverse events (SAEs)
Time frame: up to 7 days after the last dose of study medication
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...and 8 more locations