Long-term safety and efficacy of lasmiditan for acute treatment of migraine: Final results of the GLADIATOR study. (14th September 2020)

• Record Type: Journal Article
• Authors: Brandes, Jan Lewis; Klise, Suzanne; Krege, John H; Case, Michael; Khanna, Rashna; Vasudeva, Raghavendra; Raskin, Joel; Kudrow, David
• Is Part Of: Cephalalgia reports. Volume 3(2020)
• Publication Date: 2020-09-14
• Subjects: 5-HT1F agonist -- ditan -- episodic migraine -- MIDAS -- serotonin; Headache -- Periodicals; Headache -- Treatment -- Periodicals; 616.8491
• DOI: 10.1177/2515816320958176
• Languages: English
• ISSNs: 2515-8163

Abstract

GLADIATOR was a prospective, randomized, open-label, phase 3 study of lasmiditan 100 mg or 200 mg dosed intermittently for up to 1 year in patients with episodic migraine. Most patients had completed one of two single-attack studies before participation. A total of 2030 patients received ≥1 lasmiditan dose and 19, 879 migraine attacks were treated. Safety results were similar to the previously reported interim analysis. The most frequently reported treatment-emergent adverse events (TEAEs) included dizziness (18.5%), somnolence (8.5%), and paresthesia (6.8%), with frequency of adverse events appearing to decrease with subsequently treated attacks. At 2 h post-dose, 26.7% and 32.2% of all attacks treated with lasmiditan 100 mg and 200 mg, respectively, were pain free. This pattern was generally consistent across study quarters and treated attacks. In conclusion, during a 1-year treatment period, intermittent lasmiditan for episodic migraine treatment was associated with generally decreasing TEAEs and consistent efficacy.