Table 3.
Summary of fremanezumab RCTs
| Study | Phase | Migraine/N | Study period | Primary outcome |
|---|---|---|---|---|
|
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) |
|
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