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. 2022 Apr 14;19(3):922–930. doi: 10.1007/s13311-022-01230-x

Table 3.

Summary of fremanezumab RCTs

Study Phase Migraine/N Study period Primary outcome

NCT02025556

Bigal et al. (2015) [30]

II

HFEM

N = 297

3 months

placebo: −3.46

225 mg: −6.27 (p < 0.001)

675 mg: −6.09 (p < 0.001)

NCT02621931 Silberstein et al. (2017) (HALO-CM) [31] III

CM

N = 1130

3 months

placebo: −2.5

225 mg: −4.6 (p < 0.001)

675 mg: −4.3 (p < 0.001)

NCT02629861 Dodick et al. (2018) (HALO-EM) [32] III

EM

N = 875

3 months

placebo: −2.2

225 mg: −3.7 (p < 0.001)

675 mg: −3.4 (p < 0.001)

NCT03308968

Ferrai et al. (2019) (FOCUS) [33]

III

EM, CM

N = 838

3 months

placebo: −0.6

225 mg: −4.1 (p < 0.001)

675 mg: −3.7 (p < 0.001)

All studies required ≤ 2 classes of failed preventive treatments. Primary outcome was MMD reduction for all studies. 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