Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN).

Abstract

BACKGROUND:

We studied the efficacy and safety of a second dose of lasmiditan for acute treatment of migraine.

METHODS:

SAMURAI and SPARTAN were double-blind, placebo-controlled Phase 3 studies in which individuals with migraine were randomized to oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Study drug was to be taken within 4 h (h) of onset of a migraine attack (moderate or severe pain). A second dose of study drug was provided for rescue (patient not pain-free at 2 h and took a second dose 2-24 h post-first dose) or recurrence (patient pain-free at 2 h, but experienced recurrence of mild, moderate, or severe migraine pain and took a second dose 2-24 h after first dose). Randomization to second dose occurred at baseline; patients originally assigned lasmiditan were randomized to the same lasmiditan dose or placebo (2:1 ratio), and those originally assigned placebo received placebo. Data from SAMURAI and SPARTAN were pooled for efficacy and safety assessment of a second dose of lasmiditan.

RESULTS:

The proportion of patients taking a second dose was lower with lasmiditan versus placebo, and decreased with increasing lasmiditan dose; the majority who took a second dose did so for rescue. In patients taking lasmiditan as first dose, outcomes (pain free, most bothersome symptom [MBS] free) at 2 h after a second dose for rescue were similar whether the second dose was lasmiditan or placebo (p > 0.05 in all cases). In patients taking lasmiditan for first dose, outcomes at 2 h after a second dose for recurrence were as follows: lasmiditan pooled versus placebo - pain free, 50% vs 32% (p > 0.05); MBS free, 71% vs 41% (p = 0.02); pain relief, 77% vs 52% (p = 0.03). In patients whose first dose was lasmiditan, the incidence of treatment emergent adverse events (TEAEs) reported after the second dose was similar whether second dose was lasmiditan or placebo.

CONCLUSIONS:

A second dose of lasmiditan showed some evidence of efficacy when taken for headache recurrence. There was no clear benefit of a second dose of lasmiditan for rescue treatment. The incidences of TEAEs were similar whether the second dose was lasmiditan or placebo.

TRIAL REGISTRATION:

SAMURAI ( NCT02439320 ) [April 2015]. SPARTAN ( NCT02605174 ) [May 2016].

• Authors: Li Shen Loo, Brian M Plato, Ira M Turner, Michael G Case, Joel Raskin, Sherie A Dowsett, John H Krege
• Journal: BMC neurology (BMC Neurol) Vol. 19 Issue 1 Pg. 191 (Aug 13 2019) ISSN: 1471-2377 [Electronic] England
• PMID: 31409292 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Benzamides
• Piperidines
• Pyridines
• Serotonin Receptor Agonists
• lasmiditan

Topics

• Adult
• Benzamides (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Piperidines (administration & dosage, adverse effects)
• Pyridines (administration & dosage, adverse effects)
• Recurrence
• Serotonin Receptor Agonists (administration & dosage, adverse effects)