Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Dec;9(2):459-471.
doi: 10.1007/s40120-020-00185-5. Epub 2020 May 23.

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

Timothy Smith  1 , John H Krege  2 , Suchitrita S Rathmann  2 , Sherie A Dowsett  2 , Ann Hake  2   3 , Emel S M Nery  2 , Brandy R Matthews  2   3 , Erin G Doty  4
Affiliations

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

Timothy Smith et al. Neurol Ther. 2020 Dec.

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.

PubMed Disclaimer

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)
See this image and copyright information in PMC

References

    1. Dodick DW. Migraine. Lancet. 2018;391:1315–1330. doi: 10.1016/S0140-6736(18)30478-1. - DOI - PubMed
    1. Abu Bakar N, Tanprawate S, Lambru G, et al. Quality of life in primary headache disorders: a review. Cephalalgia. 2016;36:67–91. doi: 10.1177/0333102415580099. - DOI - PubMed
    1. Leonardi M, Raggi A, Ajovalasit D, et al. Functioning and disability in migraine. Disabil Rehabil. 2010;32:S23–S32. doi: 10.3109/09638288.2010.511687. - DOI - PubMed
    1. Chaushev N, Milanov I. Impact of migraine and migraine treatment on patient’s capacity to work and quality of life. J Clin Med. 2009;2:26–31.
    1. Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343–349. doi: 10.1212/01.wnl.0000252808.97649.21. - DOI - PubMed

Associated data

LinkOut - more resources