Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine

Table 2 Adverse event summary over the course of the study (safety population)

	Placebo (N=500)	Lasmiditan 100 mg (N=485)	Lasmiditan 200 mg (N=486)
Across Attacks:
Attacks treated	≤3	≤4	≤4
Deaths	0	0	0
Serious AE^a, n (%)	7 (1.4)	7 (1.4)	8 (1.6)
Study discontinuation due to AE^b, n (%)	6 (1.2)	36 (7.4)	38 (7.8)
1st attack only:
% reporting ≥ 1 TEAE	22.4	53.0	61.1
Most common TEAEs
- Dizziness	23 (4.6)	108 (22.3)	129 (26.5)
- Paresthesia	9 (1.8)	39 (8.0)	62 (12.8)
- Fatigue	9 (1.8)	37 (7.6)	46 (9.5)
- Nausea	19 (3.8)	31 (6.4)	49 (10.1)
- Vertigo	1 (0.2)	24 (4.9)	33 (6.8)
- Somnolence	7 (1.4)	20 (4.1)	37 (7.6)

Abbreviations : AE adverse event, TEAE treatment-emergent AE
^aOf the serious AEs, 5 were considered treatment emergent: Placebo =2 (liver disorder, suicidal ideation); lasmiditan 100 mg=1 (asthma); lasmiditan 200 mg=2 (hemiplegic migraine [judged unrelated to study drug by investigator] and serotonin syndrome [met Sternbach’s and Hunter’s criteria] )
^bDizziness most common TEAE leading to discontinuation

ISSN: 1129-2377