Lasmiditan was superior to placebo for helping patients with migraine achieve pain freedom at 2 hours, a study in the Journal of Headache and Pain reports.
The study was an analysis of findings from the double-blind, phase 3, placebo-controlled SAMURAI and SPARTAN trials. Patients in the 2 trials were aged ≥18 years and reported 3 to 8 migraine attacks per month. In the trials, patients were randomly assigned to either oral lasmiditan at 50 mg (SPARTAN trial only), 100 mg, 200 mg, or placebo. The cohorts were also stratified by patients who were using ≥1 preventive treatment (n=698) and patients not using preventive treatments (n=3283). Preventives were only allowed if dosages were stable for 3 months before screening.
The primary outcome of pain-free status at 2 hours was assessed in lasmiditan and placebo groups and within subgroups of patients using preventives and not using preventives. Secondary outcomes included pain relief at 2 hours, sustained pain freedom at 24 hours, total migraine freedom at 2 hours, disability-free status at 2 hours, and a global impression of change rating of “very much better” or “much better’ at 2 hours.
In patients who used preventives, all dosages of lasmiditan were associated with a significantly greater proportion achieving a pain-free status at 2 hours vs placebo (P <.05). Pain freedom was achieved as early as 1 hour following treatment with 200 mg lasmiditan (P <.05) and by 2 hours for all other doses (P <.05). In analyses comparing patients who used preventives with patients who did not use preventives, there were no differences in terms of the primary efficacy outcome, freedom from most bothersome symptoms at 2 hours, and all other efficacy outcomes (all interaction P ≥.01). No differences were found between subgroups with regard to adverse event rates.
Limitations of the analysis were the inclusion of only 1 lasmiditan 50-mg treatment group in 1 of the 2 trials, as well as the small number of patients in each specific treatment group for individual preventive agents.
The findings from these 2 trials “indicate that lasmiditan was effective and had no increased safety or tolerability issues in patients using concomitant migraine preventive medications available during the trials,” the investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. This clinical trial was supported by Eli Lilly and Company. Please see the original reference for a full list of authors’ disclosures.
Loo LS, Ailani J, Schim J, et al. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019;20(1):84.