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Background

What do we already know about this topic?

  • A preventative treatment that delivers rapid clinical benefit remains an unmet need in migraine.
  • Eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody (anti-CRGP mAb) demonstrated efficacy and a rapid onset of action in two Phase III, double-blind, randomized, placebo-controlled trials (PROMISE-1 and PROMISE-2) that evaluated eptinezumab for migraine prevention.1,2
  • A post-hoc analysis was carried out to confirm whether the percentage of patients with a migraine on Day 1 after eptinezumab administration measured onset of full preventive effect

How was this study conducted?

  • PROMISE-1 and PROMISE-2 were Phase III, double-blind, randomized, placebo-controlled clinical trials evaluating eptinezumab 100 mg, 300 mg, or placebo for migraine prevention in patients with episodic (n=888) and chronic (n=1072) patients.1,2
  • A post-hoc closed testing procedure analyzing the proportion of patients experiencing a migraine was used on progressively smaller time intervals from Weeks 1 to 12, Days 1 to 84.
  • For each interval that demonstrated statistical significance (p≤0.05), the interval was reduced by 1 day and treatment effect was tested again.
  • The procedure was stopped at the time point where statistical significance was not achieved, and the onset of preventive efficacy was declared as the end day of the prior interval.