Table 5.

Summary of fremanezumab randomized controlled trials and related open-label extension studies

Study	Phase	Inclusion criteria	Study period/n	Primary endpointa
NCT02025556 Bigal et al. [63]	II	HFEM and ≤ 2 prior classes of failed preventive treatments	3 months n = 297	MMD reduction: placebo: − 3.46 225 mg: − 6.27 675 mg: − 6.09 (both p < 0.0001)
NCT02021773 Bigal et al. [64]	II	CM and ≤ 2 prior classes of failed preventive treatments	3 months n = 264	Mean reduction of headache h: placebo: − 37.10 675/225 mg: c − 59.84 (p = 0.0386) 900 mg: − 67.51 (p = 0.0057)
NCT02621931 Silberstein et al. (HALO-CM) [65]	III	CM and < 2 prior classes of failed preventive treatments	3 months n = 1130	MHD reduction: placebo: − 2.5 225 mg: − 4.6 675 mg: − 4.3 (both p < 0.001)
NCT02638103 Goadsby et al. [65]b			12 months n = 1110	MMD reduction: 225 mg: − 8.0 675 mg: − 7.2
NCT02629861 Dodick et al. (HALO-EM) [66]	III	EM and < 2 prior classes of failed preventive treatments	3 months n = 875	MMD reduction: placebo: − 2.2 225 mg: − 3.7 675 mg: − 3.4 (both p < 0.001)
NCT02638103 Goadsby et al. [67]b			12 months n = 780	MMD reduction: 225 mg: − 5.1 675 mg − 5.2
NCT03308968 Ferrai et al. (FOCUS) [68]	III	EM or CM and 2–4 prior classes of failed preventive treatments	3 months n = 838	MMD reduction: placebo: − 0.6 225 mg: − 4.1 675 mg: − 3.7 (all p values < 0.0001)
NCT03303079 Sakai et al. [69]	III	CM and < 2 prior classes of failed preventive treatments	3 months n = 571	MHD reduction: placebo: − 2.4 225 mg: − 4.1 675 mg: − 4.1 (both p < 0.001)

All fremanezumab treatments were given intravenously. Fremanezumab 225 mg dosages were given monthly, 675 mg dosages were given every 3 months

EM episodic migraine, HFEM high-frequency episodic migraine, CM chronic migraine, MMD mean monthly migraine day, MHD monthly headache day

^ap Values are results compared against placebo

^bOpen-label extension study

^cPatients received 675 mg in the first month, followed by doses of 225 mg in the second and third months