Profile of Lasmiditan in the Acute Treatment of Migraine in Adults: Design, Development, and Place in Therapy

Figures & data

Figure 1 Biochemical structure of Lasmiditan. This compound exhibits a pyridinoyl-piperidine scaffold, which is not found in other anti-migraine rescue therapies and is thought to contribute to its unique properties.¹¹

Table 1 Efficacy of Lasmiditan Clinical Studies in Acute Migraine

Study	Type	Phase	Study Design	Primary Endpoint	LAS Dosage	Number of Subjects	Duration	Efficacy	Reference
NCT00384774	RCT, Proof-of-concept, dose-finding study	II	MC, R, DB, PC	Headache response (moderate-to-severe down to mild or no headache at 2h)	10 mg IV 20 mg IV 30 mg IV 45 mg IV	LAS: 88 PLC: 42	24 Hours	LAS: 54–75% (linear association response by dose) PLC: 45% P = 0.0126	Ferrari et al, 2010^Citation21
NCT00883051	RCT, dose-ranging, proof-of-concept study	II	MC, R, DB, PC	Headache response at 2h (moderate-to-severe down to mild or no headache at 2h)	50 mg PO 100 mg PO 200 mg PO 400 mg PO	LAS: 305 79 (50 mg) 81 (100 mg) 69 (200 mg) 68 (400 mg) PLC: 81	24 hours, 14 day FU	LAS: 50 mg: 34/79, 43%; 17.9% difference 100 mg: 52/81, 64%; 38.2% difference 200 mg: 35/69, 51%; 28.8% difference 400 mg: 44/68, 65%; 38.7% difference PLC: 21/81, 25.9%	Farkkila et al, 2012^Citation22
NCT02439320, SAMURAI	Pivotal	III	MC, R, DB, PC	Headache freedom at 2h (200 mg dose)	100 mg PO 200 mg PO	LAS: 1239 630 (100 mg) 609 (200 mg) PLC: 617	7 days (treated) 8 weeks (not treated)	LAS: 100 mg: 28.2%; OR 2.2, 95% CI 1.6–3.0, p<0.001 200 mg: 32.2%; OR 2.6; 95% CI 2.0–3.6, p<0.001 PLC: 15.3%	Kuca et al, 2018^Citation23
NCT02605174, SPARTAN	Pivotal	III	MC, R, DB, PC	Headache freedom at 2 hours MBS freedom at 2 hours	50 mg PO 100 mg PO 200 mg PO	LAS: 1938 654 (50 mg) 635 (100 mg) 649 (200 mg) PLC: 645	48 hours, 7 day FU	Headache Freedom at 2h: LAS: 50 mg: 28.6%, OR 1.5, 95% CI 1.1–1.9, P = 0.003 100 mg: 31.4%, OR 1.7, 95% CI 1.3–2.2, P<0.001 200 mg: 38.8%, OR 2.3, 95% CI 1.8 −3.1, P<0.001 PLC: 21.3% MBS Freedom at 2h: LAS: 50 mg: 40.8%, OR 1.4, 95% CI, 1.1–1.8, P=0.009 100 mg: 44.2%, OR 1.6, 95% CI 1.2–2.0, P<0.001 200 mg: 48.7%, OR 1.9, 95% CI 1.4–2.4, P<0.001 PLC: 33.5%	Goadsby et al, 2019^Citation24
NCT03670810, CENTURION	RCT	III	MC, R, DB, PC	Headache freedom at 2h (first attack) Headache freedom at 2h (>2 of 3 attacks)	100 mg PO 200 mg PO	LAS: 806 408 (100 mg) 398 (200 mg) PLC: 443	48 hours, 2 and 3 month FU	Headache Freedom at 2h: LAS: 100 mg: 25.8%, OR 3.8, 95% CI 2.6–5.7, P<0.001 200 mg: 29.3%, OR 4.6 95% CI 3.1–6.8, P<0.001 PLC: 8.4% Headache Freedom at 2h in ≥ 2 of 3 attacks: LAS: 100 mg: 14.4%, OR 3.8, 95% CI 2.1–6.8 200 mg: 24.4%, OR 7.2, 95% CI 4.1–12.7 PLC: 4.3%	Ashina et al, 2021^Citation25
NCT03962738, MONONOFU	RCT	II	MC, R, DB, PC	Headache freedom at 2h	50 mg PO 100 mg PO 200 mg PO	LAS: 471 85 (50 mg) 207 (100 mg) 179 (200 mg) PLC: 211	48 hours, 3–28 days FU	Headache Freedom at 2h: LAS: 50 mg: 23%, OR 1.55, 95% CI 0.83–2.87, P = 0.167 100 mg: 32.4%, OR 2.41, 95% CI 1.51–3.83, P<0.001 200 mg: 40.8%, OR 3.46, 95% CI 2.17–5.54, P<0.001 PLC: 16.6%	Sakai et al, 2021^Citation26

Abbreviations: DB, double-blind; FU, follow-up; IV, intravenous; LAS, lasmiditan; MBS, most bothersome symptom; MC, multi-center; OL, open-label; OR, odds ratio; PC, placebo-controlled; PLC, placebo; PO, oral; R, randomized; RCT, randomized clinical trial.

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