Patients with migraine who took lasmiditan (Reyvow) for acute pain during attacks had greater odds of reaching pain freedom, according to results of a phase 3 trial.
Patients with migraine who took lasmiditan (Reyvow) for acute pain during attacks had greater odds of reaching pain freedom, according to results of a phase 3 trial presented earlier this month at the PAINWeek 2020 Live Virtual Conference.
The mean age of the participants, 84% of whom were female, was 41; they had suffered from migraines for nearly 13 years. The mean Migraine Disability Assessment Score was 31.9.
The CENTURION study included 1471 participants; they were randomized and received at least 1 dose of either lasmiditan 200 mg (n = 486) or 100 mg (n = 485) or control treatment (placebo for some but not all attacks; n = 500) per attack.
The trial assessed efficacy and safety, including consistency of response across 4 attacks. Study participants, including those with and without aura, treated a migraine attack when their pain was at least of moderate severity and within 4 hours after pain onset. They entered results into an electronic diary at 30 minutes and 60 minutes, as well as 2, 4, 6, 24, and 48 hours after dosing.
Coprimary efficacy end points included pain freedom at 2 hours for the first attack and pain freedom at 2 hours for 2 of 3 attacks. Secondary end points included pain freedom at 60 minutes, sustained pain freedom at 24 and 48 hours, and pain relief at 1 hour and 2 hours, among others.
Eli Lilly, the maker of the drug, also said lasmiditan showed superiority over placebo in all gated end points, including proportions of study participants who reported pain freedom at 1 hour (200-mg dose), pain relief at 1 hour and 2 hours (both doses), sustained pain freedom at 24 hours (both doses) and 48 hours (200-mg dose), and no disability at 2 hours (both doses).
In addition, patients who previously did not respond sufficiently to triptans reached pain freedom at 2 hours.
At doses of 100 mg or 200 mg, adults had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours when treating their first migraine attack. Pain freedom is defined as a reduction of pain at baseline to no pain.
Compared with patients receiving placebo, lasmiditan 200 mg resulted in a therapeutic gain of approximately 21 percentage points (29.3% vs 8.4%; odd ratio, 4.6; P < .001).
At lasmiditan 100 mg, there was a a therapeutic gain of approximately 17 percentage points compared with placebo (25.8% vs. 8.4%; P < .001).
At 24 hours, participants on both doses of Lasmiditan had greater odds of having sustained relief (P < .001) compared with placebo:
At 48 hours and 200 mg, patients had 4.1 times greater odds of reaching sustained relief (15.4% vs. 4.3%; P < .001).
Krikke-Workel J, Krege JH, Ashina M, et al. Randomized, controlled trial of lasmiditan over four migraine attacks: first attack findings. Presented at: PAINWeek 2020 Live Virtual Conference; September 8-12, 2020.