Lasmiditan May Be Effective for the Acute Treatment of Migraine
Investigators analyzed the efficacy and safety findings from two randomized placebo-controlled phase 3 trials.
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The acute treatment of migraine with lasmiditan may be safe and associated with short-term freedom from headache pain and reductions in bothersome headache symptoms, according to results from 2 phase 3 trials to be presented at the World Congress on Pain 2018 conference, held September 12-16 in Boston, Massachusetts.
Investigators analyzed the efficacy and safety findings from 2 randomized placebo-controlled phase 3 trials (SAMURAI, Clinicaltrials.gov identifier: NCT02439320 and SPARTAN, Clinicaltrials.gov identifier: NCT02605174). Patients included in both trials had 3 to 8 migraine attacks per month and had moderate disability, as assessed by a Migraine Disability Assessment Score ≥11. In the SAMURAI study, researchers randomly assigned patients to receive lasmiditan 200 mg (n=518), lasmiditan 100 mg (n=503), or placebo (n=524). In the SPARTAN study, patients were randomly assigned 1:1:1:1 to receive lasmiditan 200 mg (n=528), lasmiditan 100 mg (n=532), lasmiditan 50 mg (n=556), or placebo (n=540).
Treatment and placebo were taken within 4 hours of migraine onset. A randomly assigned second treatment or placebo dose was provided for rescue or recurrence. Primary and secondary end points were the percentage of patients who were headache pain free and free from most bothersome symptoms at 2 hours after the initial treatment dose, respectively. Treatment safety was assessed by occurrence of treatment-emergent adverse events.
In the SAMURAI study, a greater percentage of patients who received lasmiditan 200 mg and lasmiditan 100 mg vs placebo were headache pain free at 2 hours after the first dose (32.2% and 28.2% vs 15.3%, respectively; P <.001 for both), as well as free from most bothersome symptoms (40.7% and 40.9% vs 29.5%, respectively; P <.001 for both). In addition, more patients receiving lasmiditan at either dose reported headache relief compared with those taking placebo (59% vs 42.2%, respectively; P <.001).
A greater percentage of patients receiving lasmiditan 200 mg, lasmiditan 100 mg, and lasmiditan 50 mg in the SPARTAN trial were headache pain free at 2 hours compared with those taking placebo (38.8% [P <.001], 31.4% [P <.001], and 28.6% [P <.01] vs 21.3, respectively). More patients receiving lasmiditan 200 mg (48.7%; P <.001), 100 mg (44.2%; P <.001), or 50 mg (40.8%; P <.01) were free from most bothersome symptoms compared with those receiving placebo (33.5%). Treatment-emergent adverse events associated with lasmiditan were mostly mild or moderate in severity and included dizziness, fatigue, lethargy, paresthesia, somnolence, and nausea.
Buchanan A, Wietecha L, Kuca B, Asafu-Adjei J, Aurora S. Lasmiditan for acute treatment of migraine: consistent efficacy and safety findings from two randomized, placebo-controlled phase 3 studies (SAMURAI, SPARTAN). Presented at: World Congress on Pain 2018; September 12-16, 2018; Boston, MA. Poster 65509.
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