Format

Send to

Choose Destination
BMC Neurol. 2019 Aug 13;19(1):191. doi: 10.1186/s12883-019-1420-5.

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).

Author information

1
Eli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA. loo_li_shen@lilly.com.
2
Norton Neuroscience Institute, 3991 Dutchmans Ln #310, Louisville, KY, 40207, USA.
3
The Center for Headache Care and Research, Island Neurological Associates PC, An affiliate of ProHealthcare, 824 Old Country Rd, Plainview, NY, 11803, USA.
4
Eli Lilly and Company, Corporate Center, Indianapolis, IN, 46285, USA.

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].

KEYWORDS:

Lasmiditan; Phase 3; Recurrence; Rescue; Second dose

PMID:
31409292
PMCID:
PMC6691529
DOI:
10.1186/s12883-019-1420-5
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center