Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies

Timothy Smith, John H Krege, Suchitrita S Rathmann, Sherie A Dowsett, Ann Hake, Emel S M Nery, Brandy R Matthews, Erin G Doty, Timothy Smith, John H Krege, Suchitrita S Rathmann, Sherie A Dowsett, Ann Hake, Emel S M Nery, Brandy R Matthews, Erin G Doty

Abstract

Introduction: Migraine is associated with substantial functional impairment and affects many aspects of daily life.

Methods: Using data from SAMURAI and SPARTAN (double-blind, placebo-controlled, phase 3 studies) and GLADIATOR (an open-label, phase 3 study enrolling patients who had completed SAMURAI or SPARTAN), we assessed the effects of lasmiditan on migraine-related functional disability at multiple time points from 0.5 to 48 h post dose by asking patients to rate how much the migraine was interfering with normal activities. Pooled data from SAMURAI and SPARTAN (SAMURAI + SPARTAN) and data from GLADIATOR were analyzed using the intention-to-treat populations.

Results: For SPARTAN + SAMURAI, significantly more patients who received lasmiditan at any dose versus placebo reported freedom from migraine-related functional disability at every timepoint from 2 h post dose, and this difference persisted to 48 h (p < 0.05). Significant differences from placebo in freedom from migraine-related functional disability commenced at 1 h post dose for lasmiditan 200 mg, 1.5 h for lasmiditan 100 mg, and 2 h for lasmiditan 50 mg. Findings from GLADIATOR supported those from SAMURAI + SPARTAN.

Conclusion: All doses of lasmiditan resulted in an improvement in migraine-related functional disability that persisted to 48 h. In SAMURAI + SPARTAN, a significant difference from placebo was observed as early as 1 h post dose. TRIAL REGISTRATION AT CLINICALTRIALS.GOV: SAMURAI (NCT02439320), SPARTAN (NCT02605174), and GLADIATOR (NCT02565186).

Keywords: Disability; Function; Lasmiditan; Migraine.

Figures

Fig. 1
Fig. 1
Migraine-related functional disability by treatment group and timepoint - SAMURAI+SPARTAN by a NRI method and b observed case analysis
Fig. 2
Fig. 2
Migraine-related functional disability by treatment group and time point - GLADIATOR (first attack) by a NRI method and b observed case analysis
Fig. 3
Fig. 3
Percent of patients with no disability by pain freedom (yes versus no) over time in a SAMURAI+SPARTAN and b GLADIATOR (observed case analysis)
Fig. 4
Fig. 4
Percent of patients who were much or very much better on the Global Impression of Change by pain freedom (yes versus no) at 2 hours in a SAMURAI+SPARTAN and b GLADIATOR (observed case analysis)
Fig. 5
Fig. 5
Percent of patients with no disability by reporting (yes versus no) of common TEAE - SAMURAI+SPARTAN (lasmiditan dosing groups only)

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