A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Summary

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

Timeline

Start

2019-06-24

Primary completion

2020-06-12

Completion

2021-07-08

Outcome

Met primary endpoint

paper Both primary endpoints were met for lasmiditan 100 mg and 200 mg (p < 0.001). PMID 33541117 ↗

registry analysis (superiority test); 100 mg Lasmiditan vs Placebo; p <0.001; Odds Ratio (OR) 3.83 (95% CI 2.56 to 5.73); Regression, Logistic NCT03670810 ↗

registry analysis (superiority test); 100 mg Lasmiditan vs Placebo; p <.001; Odds Ratio (OR) 3.77 (95% CI 2.10 to 6.76); Regression, Logistic NCT03670810 ↗

Publications

• Komori M, Ozeki A, Tanji Y, Kamiki E, Krege JH, Li LQ, Suzuki S, Shibata M, Takeshima T. Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial. J Headache Pain. 2024 Mar 25;25(1):43. doi: 10.1186/s10194-024-01745-y.
• Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.
• Ashina M, Roos C, Li LQ, Komori M, Ayer D, Ruff D, Krege JH. Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial. Cephalalgia. 2023 Apr;43(4):3331024231161745. doi: 10.1177/03331024231161745.
• Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.
• MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
• Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
• Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.
• Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
• Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.
• Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
• Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lasmiditan	Small molecule	50 mg	Oral
Subject	Lasmiditan	Small molecule	100 mg	Oral
Subject	Lasmiditan	Small molecule	200 mg	Oral

Indications