The open-label, 12-month, phase 3 GLADIATOR trial evaluated the efficacy of the novel, selective 5-HT1F receptor agonist lasmiditan in treating migraine attacks of mild versus moderate or severe pain severity . Treating migraine attacks at mild pain showed a tendency to relatively better efficacy outcomes, suggesting that earlier dosing is beneficial.
It is recommended to treat acute migraine attacks early, when pain is mild. In two phase 3, placebo-controlled, single-attack clinical trials (SAMURAI and SPARTAN), lasmiditan was superior to placebo in treating moderate-to-severe migraine attacks. However, few mild attacks were studied in this phase 3 program.
The current analysis assessed data from the prospective, randomised, open-label, phase 3 trial GLADIATOR. Patients randomly received lasmiditan 100 or 200 mg. Data of almost 18,000 treated migraine attacks in nearly 2,000 patients was evaluated.
Two-thirds of attacks (65.1%) were treated when pain was moderate and one-third (33.3%) when pain was severe. A minority of attacks (1.5%) was treated when pain was mild. Average time from headache onset to treatment administration was 1.3 hours, which was not different for mild, moderate, or severe attacks.
Efficacy measures included the proportion of attacks with 2-hour pain freedom, 2-hour most-bothersome symptom freedom, and 24-hour sustained-pain freedom. In a relatively greater proportion of mild attacks, (sustained) pain freedom and freedom of most bothersome symptoms were achieved during treatment with lasmiditan.
One or more treatment-emergent adverse events (AE) were reported in 16.8% of mild migraine attacks, 14.3% of moderate attacks, and 10.2% of severe attacks. The most frequent treatment-emergent AE was dizziness, which was irrespective of headache intensity across the attacks.
Relatively better efficacy outcomes were observed when lasmiditan treatment was initiated at mild versus moderate or severe pain. Further research is needed to better understand the relationship of lasmiditan outcomes to time of administration in the course of migraine attacks.
- Peres MF. Lasmiditan efficacy in mild versus moderate or severe migraine headaches. MTIS 2020 Virtual Symposium, abstract MTV20-DP-030.
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