The 20120295 study was a 12-week, global, randomized, double-blind, placebo-controlled, Phase 2 trial evaluating the efficacy and safety of erenumab as prophylaxis in 667 patients with chronic migraine. Patients either received subcutaneous erenumab 70mg, erenumab 140mg, or placebo once monthly. The primary endpoint was change in monthly migraine days from baseline to the last 4 weeks of the 12-week treatment phase (number of migraine days between Weeks 9 and 12). Secondary endpoints included reduction of ≥50% from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication days and change from baseline in cumulative monthly headache hours.
The study met its primary endpoint, showing a statistically significant reduction in migraine days for erenumab. Patients treated with either 70mg or 140mg dose of erenumab experienced a 6.6-day reduction from baseline in monthly migraine days vs. a 4.2-day reduction in placebo-treated patients. Erenumab was shown to have a similar safety profile as placebo, with the most common adverse events including injection site pain, upper respiratory tract infection and nausea. Further analyses of the study data is ongoing and will be presented at a future medical meeting and submitted for publication.
Erenumab is a fully human monoclonal antibody designed to target the Calcitonin-Gene-Related-Peptide (CGRP) receptor.
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