EPISODIC MIGRAINE (ADVANCE STUDY)

ADVANCE study design¹

After a 28-day baseline period, a total of 910 patients were randomized 1:1:1:1 to receive (once daily for 12 weeks) either:

●QULIPTA 10 mg (n=222);

●QULIPTA 30 mg (n=230);

●QULIPTA 60 mg (n=235); or

●Placebo (n=223)

Primary efficacy endpoint:

●The change from baseline in mean MMD across the 12-week treatment period

Secondary endpoints:

●The change from baseline in mean monthly headache days

●The proportion of patients achieving a ≥50% reduction from baseline in mean MMD (average over 12 weeks)

Select patient characteristics¹

Baseline characteristics:

●Mean age (range): 42 years (18—73)

●Sex: 89% female; 11% male

Inclusion/exclusion criteria:

●Patients were included if they had a diagnosis of migraine (per ICHD-3 criteria) for at least 1 year with or without aura;

●Patients could use acute medications during the study such as triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids as needed;

●The study excluded patients with clinically significant liver disease at screening and myocardial infarction, stroke, or transient ischemic attacks within 6 months prior to screening.