Treatment with lasmiditan was found to be associated with higher rates of freedom from pain and total migraine freedom compared with placebo in patients with migraine, according to study results published in Headache.
The researchers analyzed data from 2 randomized double-blind placebo-controlled phase 3 clinical trials, SPARTAN and SAMURAI, which included a total of 5236 participants with migraine as defined by the International Classification of Headache Disorders-II. Participants with migraine for ≥1 year and with 3 to 8 migraine attacks per month were randomly assigned to receive lasmiditan (50 mg, n=750; 100 mg, n=1498; 200 mg, n=1495) or placebo (n=1493).
Data were collected at baseline and every 30 minutes thereafter for up to 2 hours following intake of lasmiditan or placebo. The researchers used these data to examine the effects on efficacy measures, including pain freedom, most bothersome symptom freedom, pain relief, freedom from associated individual symptoms (photophobia, phonophobia, or nausea), total migraine freedom (defined as pain freedom and freedom from associated symptoms), and freedom from migraine-related functional disability. They also determined time to meaningful headache relief and time to first becoming pain free.
Starting at 60 minutes, participants taking lasmiditan 100 mg and 200 mg vs placebo had higher rates of pain freedom (placebo 7.0%; lasmiditan 100 mg, 10.0%, P =.012; lasmiditan 200 mg, 15.5%, P <.001) and higher rates of total migraine freedom (placebo 6.1%; lasmiditan 100 mg, 8.9%, P =.017; lasmiditan 200 mg, 12.4%, P <.001).
Participants taking lasmiditan at 100 mg or 200 mg had higher rates of freedom from most bothersome symptom (placebo 7.9%; lasmiditan 100 mg, 11.1%, P =.015; lasmiditan 200 mg, 13.0%, P <.001) as well as pain relief (placebo 13.4%; lasmiditan 100 mg, 17.5%, P =.007; lasmiditan 200 mg, 19.1%, P <.001) beginning as early as 30 minutes after treatment.
A greater percentage of participants in the lasmiditan 200-mg group reported freedom from photophobia (13.7%, P =.005) and phonophobia (17.4%, P =.042) compared with those taking placebo (9.2% and 13.4%, respectively) starting 30 minutes after treatment.
At 90 and 120 minutes, participants in all lasmiditan groups reported improvements in all efficacy measures except freedom from nausea compared with placebo. Participants taking lasmiditan were more likely to achieve meaningful headache relief and to become headache free within 24 hours compared with those given placebo (P <.001).
This clinical trial was supported by CoLucid Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.
Ashina M, Vasudeva R, Jin L, et al. Onset of efficacy following oral treatment with lasmiditan for the acute treatment of migraine: integrated results from 2 randomized double-blind placebo-controlled phase 3 clinical studies [published online September 17, 2019]. Headache. doi:10.1111/head.13636