Novel Oral Treatment Safe, Effective for Migraine Headache Relief
A greater proportion of patients treated with lasmiditan were headache-free at 2 hours after treatment compared with placebo.
|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO — Lasmiditan is effective and safe for the treatment of migraine headache, according to study findings presented at the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1, 2018 in San Francisco, California.
“As an oral, first-in-class molecule, lasmiditan represents the first significant innovation in the acute treatment of migraine in 20 years,” Joel Raskin, MD, FRCPC, the Medical Affairs leader for lasmiditan at Eli Lilly, told Neurology Advisor. “Lasmiditan has been designed to target receptors associated with migraine without the vasoconstrictor activity associated with some migraine therapies.”
The 2 randomized, phase 3, double-blind studies included in this presentation were the SAMURAI (ClinicalTrials.gov Identifier: NCT02439320) and SPARTAN (ClinicalTrials.gov Identifier: NCT02605174) trials. Patients reported moderate disability associated with their migraine (Migraine Disability Assessment Score ≥11) and a total of 3 to 8 migraine episodes per month.
In the SAMURAI trial, patients were randomly assigned (1:1:1) to 200 mg lasmiditan, 100 mg lasmiditan, or placebo, whereas patients in the SPARTAN trial were assigned to either 200 mg lasmiditan, 100 mg lasmiditan, 50 mg lasmiditan, or placebo in a 1:1:1:1 ratio. The proportion of patients achieving a headache-free status at 2 hours following treatment comprised the primary outcome, whereas the secondary outcome was comprised of the proportion of patients who were free from their most bothersome symptom (MBS) at 2 hours following treatment.
A significantly greater proportion of patients receiving 200 mg lasmiditan in the SAMURAI (32.2% vs 15.3%) and SPARTAN (38.8% vs 21.3%) trials achieved headache-free status at 2 hours post-first dose compared with patients receiving placebo (P <.001). Additionally, a greater proportion of patients receiving lasmiditan were free of MBS approximately 2 hours following the first dose compared with patients assigned to the placebo group (lasmiditan 200 mg: SAMURAI 40.7%, SPARTAN 48.7%; placebo: SAMURAI 29.5%, SPARTAN 33.5%). The majority of treatment-emergent events were mild-to-moderate in severity and included dizziness, fatigue, lethargy, paresthesia, somnolence, and nausea.
“If approved, lasmiditan may provide a much-needed, new treatment for patients in need, including those who may be poorly served by existing therapies or those with cardiovascular disease or risk factors,” Dr Raskin said.
Disclosures: The SPARTAN and SAMURAI trials were sponsored by Eli Lilly and Company.
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Wietecha LA, Kuca B, Asafu-Adjei J, Aurora SK. Phase 3 studies (SAMURAI, SPARTAN) of lasmiditan compared to placebo for acute treatment of migraine. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 448819