Stauffer VL, et al. - The EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) study was a double-blind, randomized, placebo-controlled trial (January 11, 2016, to March 22, 2017) carried out to see if galcanezumab was better than placebo in the preventing an episodic migraine with or without aura. It was observed that galcanezumab 120-mg and 240-mg monthly injections gave clinical advantages and resulted in better functioning. Researchers reported that the incidence rate of adverse events was low.

Methods

• Galcanezumab (120 mg and 240 mg) vs placebo were compared in this multicenter, clinic-based study, including 90 sites in North America.
• Study participants were adults (aged 18 to 65 years) with at least a 1-year history of migraine, 4 to 14 migraine headache days per month and a mean of at least 2 migraine attacks per month within the past 3 months, and were diagnosed prior to age 50 years.
• No other preventive medications were allowed during the study.
• An aggregate of 1,671 patients were analyzed; 809 did not meet study entry or baseline criteria, and 858 were included in the intent-to-treat population.
• For this analysis, patients were randomized (2:1:1) to monthly placebo, galcanezumab, 120 mg, and galcanezumab, 240 mg.
• Overall mean change from baseline in the number of monthly migraine headache days during the treatment period was the primary outcome.
• At least 50%, at least 75%, and 100% reduction in monthly migraine headache days, migraine headache days with acute medication use, and scores from the Migraine-Specific Quality of Life questionnaire, Patient Global Impression of Severity, and Migraine Disability Assessment were the included secondary measures.
• Treatment-emergent adverse events and serious adverse events were reported.

Results

• According to the findings obtained, of the 1,671 patients assessed, 858 (mean age, 40.7 years; 718 women [83.7%]) met study entry criteria and received at least 1 dose of investigational product.
• It was noted that treatment with galcanezumab significantly reduced monthly migraine headache days (both P < .001) by 4.7 days (120 mg) and 4.6 days (240 mg) compared with placebo (2.8 days).
• After multiplicity adjustment, all key secondary objectives were also significant.
• No meaningful differences were found between 120-mg and 240-mg doses of galcanezumab regarding effectiveness.
• The findings demonstrated that completion rate during treatment was high (81.9%; n = 718), and the incidence of discontinuation due to adverse events was less than 5% across all treatment groups.