The efficacy and safety of Emgality were evaluated in chronic migraine in a Phase 3 trial1,17
REGAIN (Study 3) was a 3-month, randomized, multicenter, double-blind, placebo-controlled trial conducted in the US and 11 other countries1,17
For people with 15 or more headache days per month,
Emgality demonstrated an average reduction of 4.8 mean MHDs per month1
Emgality demonstrated an average reduction of 4.8 mean MHDs per month vs 2.7 mean MHDs per month with placebo (baseline mean: 19.4 MHDs per month vs 19.6 MHDs per month) (p<0.001)1
cp<0.001 vs placebo.
Change from baseline in mean monthly MHDs1,9de
-4.1 mean MHDs with Emgality in the first month, on average vs -1.8 mean MHDs with placebo9
dLeast-square means and 95% confidence intervals are presented.
eEarliest post-baseline, prespecified assessment.
Additional Secondary Endpoints for REGAIN Trial1
≥50% reduction of monthly MHDs was 28% with Emgality vs 15% with placebo (p<0.001)1
In REGAIN, Emgality 120 mg was not significantly better than placebo for the proportion of patients with 75% and 100% reduction from baseline in the number of monthly MHDs over the 3-month treatment period. Statistical significance vs placebo was not observed after controlling for multiple comparisons for MSQ and MHDs with acute medication use.