A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

Summary

This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

Timeline

Start

2019-05-31

Primary completion

2020-06-08

Completion

2020-06-08

Outcome

Met primary endpoint

registry NUMBER Placebo: 16.6 percentage of participants NUMBER 200 mg Lasmiditan: 40.8 percentage of participants NCT03962738 ↗

registry analysis (superiority test); Placebo vs 200 mg Lasmiditan; p <0.001; Odds Ratio (OR) 3.46 (95% CI 2.17 to 5.54); Regression, Logistic NCT03962738 ↗

Publications

• Kitamura S, Imai N, Tanji Y, Ozeki A, Komori M. Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study. J Pain Res. 2023 May 25;16:1725-1738. doi: 10.2147/JPR.S399567. eCollection 2023.
• Matsumori Y, Komori M, Tanji Y, Ozeki A, Sakai F. Rapid Onset and Sustained Efficacy of Lasmiditan Among Japanese Patients with Migraine: Prespecified Analyses of a Randomized Controlled Trial. Neurol Ther. 2022 Dec;11(4):1721-1734. doi: 10.1007/s40120-022-00403-2. Epub 2022 Sep 22.
• 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.
• Hashimoto Y, Komori M, Tanji Y, Ozeki A, Hirata K. Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial. Expert Opin Drug Saf. 2022 Dec;21(12):1495-1503. doi: 10.1080/14740338.2022.2078302. Epub 2022 Jun 24.
• 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.

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