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June 30, 2018
A greater proportion of patients treated with lasmiditan were without headache 2 hours after treatment, compared to placebo.
SAN FRANCISCO – Lasmiditan is effective and safe for the treatment of migraine, according to the results of the study presented at the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1 2018 in San Francisco, California. [19659005″Entantquemoléculeoraledepremièreclasselelasmiditanreprésentelapremièreinnovationsignificativedansletraitementaigudelamigrainedepuis20ans”adéclaréJoelRaskinMDFRCPCresponsabledesaffairesmédicaleschezLasmiditanchezEliLilly] Counselor in Neurology . "Lasmiditan has been designed to target migraine-associated receptors without the vasoconstrictor activity associated with certain migraine therapies."
The 2 randomized, phase 3, double-blind studies included in this presentation were SAMURAI (ClinicalTrials.gov Identifier: NCT02439320) and SPARTAN (ClinicalTrials.gov Identifier: NCT02605174) trials. Patients reported moderate disability associated with their migraine (Assessment of migraine disability ≥ 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 of lasmiditan, 100 mg of lasmiditan or placebo, while patients of the SPARTAN trial were received either 200 mg lasmiditan, 50 mg lasmiditan, 50 mg Lasmiditan, or placebo in a 1: 1: 1: 1 ratio. The proportion of patients achieving a non-headache state 2 hours after treatment was the primary outcome, then that the secondary endpoint was the proportion of patients who were free of their most troublesome symptoms (MBS) 2 hours after treatment.
A significantly higher proportion of patients receiving 200 mg lasmiditan in the SAMURAI studies (32.2% vs 15.3%) and SPARTAN (38.8% vs 21.3%) achieved a headache-free state 2 hours after the first dose compared to patients receiving placebo. ( P <.001). In addition, a greater proportion of patients treated with lasmiditan were free of MBS approximately 2 hours after the first dose compared to placebo patients (lasmiditan 200 mg: SAMURAI 40.7%, SPARTAN 48.7%, placebo: SAMURAI 29 , 5%, SPARTAN 33.5%). The majority of treatment-related events were mild to moderate in severity, including dizziness, fatigue, lethargy, paresthesia, drowsiness, and nausea
"If approved, lasmiditan may provide a new treatment needed to patients. need, including those who may be underserved by existing therapies or those who have cardiovascular disease or risk factors, "said Dr. Raskin.
Disclosures: The SPARTAN and SAMURAI trials were sponsored by Eli Lilly and Company.
For more details on AHS 2018, click here
Reference
LA Wietecha, Kuca B, J Asafu-Adjei, Aurora SK. Phase 3 studies (SAMURAI, SPARTAN) of lasmiditan versus placebo for the acute treatment of migraine. Presented at: 2018 Annual Scientific Meeting of the American Headache Society. June 28 to July 1, 2018; San Francisco, CA. Abstract 448819
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