BACKGROUND: We tested erenumab, a fully human monoclonal antibody that inhibits 
the calcitonin gene-related peptide receptor, for the prevention of episodic 
migraine.
METHODS: We randomly assigned patients to receive a subcutaneous injection of 
either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. 
The primary end point was the change from baseline to months 4 through 6 in the 
mean number of migraine days per month. Secondary end points were a 50% or 
greater reduction in mean migraine days per month, change in the number of days 
of use of acute migraine-specific medication, and change in scores on the 
physical-impairment and everyday-activities domains of the Migraine Physical 
Function Impact Diary (scale transformed to 0 to 100, with higher scores 
representing greater migraine burden on functioning).
RESULTS: A total of 955 patients underwent randomization: 317 were assigned to 
the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the 
placebo group. The mean number of migraine days per month at baseline was 8.3 in 
the overall population; by months 4 through 6, the number of days was reduced by 
3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as 
compared with 1.8 days in the placebo group (P<0.001 for each dose vs. placebo). 
A 50% or greater reduction in the mean number of migraine days per month was 
achieved for 43.3% of patients in the 70-mg erenumab group and 50.0% of patients 
in the 140-mg erenumab group, as compared with 26.6% in the placebo group 
(P<0.001 for each dose vs. placebo), and the number of days of use of acute 
migraine-specific medication was reduced by 1.1 days in the 70-mg erenumab group 
and by 1.6 days in the 140-mg erenumab group, as compared with 0.2 days in the 
placebo group (P<0.001 for each dose vs. placebo). Physical-impairment scores 
improved by 4.2 and 4.8 points in the 70-mg and 140-mg erenumab groups, 
respectively, as compared with 2.4 points in the placebo group (P<0.001 for each 
dose vs. placebo), and everyday-activities scores improved by 5.5 and 5.9 points 
in the 70-mg and 140-mg erenumab groups, respectively, as compared with 3.3 
points in the placebo group (P<0.001 for each dose vs. placebo). The rates of 
adverse events were similar between erenumab and placebo.
CONCLUSIONS: Erenumab administered subcutaneously at a monthly dose of 70 mg or 
140 mg significantly reduced migraine frequency, the effects of migraines on 
daily activities, and the use of acute migraine-specific medication over a 
period of 6 months. The long-term safety and durability of the effect of 
erenumab require further study. (Funded by Amgen and Novartis; STRIVE 
ClinicalTrials.gov number, NCT02456740 .).