. 2022 Apr 27;36(3):341–358. doi: 10.1007/s40259-022-00530-0

Table 3.

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

Study	Phase	Inclusion criteria	Study period/n	Primary endpoint^a
NCT01952574 Sun et al. [16]	II	EM and ≤ 2 prior classes of failed preventive treatments	3 months n = 483	MMD reduction: Placebo: − 2.3 70 mg: − 3.4 (p = 0.021) 7 mg and 21 mg not significant
Ashina et al. [17]^b	5 years n = 383	MMD reduction: − 5.3
NCT02066415 Tepper et al. [18]	II	CM and ≤ 3 prior classes of failed preventive treatments	3 months n = 667	MMD reduction: Placebo: − 4.2 70 mg: − 6.6 (p < 0.0001) 140 mg: − 6.6 (p < 0.0001)
NCT02174861 Tepper et al. [19]^b	12 months n = 451	MMD reduction: 70 mg: − 8.5 140 mg: − 10.5
NCT02456740 Goadsby et al. (STRIVE) [20]	III	EM and ≤ 2 prior classes of failed preventive treatments	4-6 months n = 955	MMD reduction: Placebo: − 1.8 70 mg: − 3.2 (p < 0.001) 140 mg: − 3.7 (p < 0.001)
Godasby et al. [21]^b	12 months n = 845	MMD reduction: 70 mg: − 4.2 140 mg: − 4.6
NCT02483585 Dodick et al. (ARISE) [22]	III	EM and ≤ 2 prior classes of failed preventive treatments	3 months n = 577	MMD reduction: Placebo: − 1.8 70 mg: − 2.9 (p < 0.001)
NCT03096834 Reuter et al. (LIBERTY) [23]	III	EM and 2-4 prior classes of failed preventive treatments	3 months n = 246	50% or greater reduction rate of MMD: Placebo: 14% 140 mg: 30% (p = 0.002)
Goadsby et al. [24]^b	64 weeks n = 204	50% or greater reduction rate of MMD: 44.3%
NCT02630459 Sakai et al. [25]	II	EM and ≤ 2 prior classes of failed preventive treatments	4–6 months n = 475	MMD reduction: Placebo: 0.06 28 mg: − 1.25 (p = 0.004) 70 mg: − 2.31 (p < 0.001) 140 mg: − 1.89 (p < 0.001)
NCT03812224 Takeshima et al. [26]	III	EM and CM, and ≤ 3 classes of failed preventive treatments	4–6 months n = 261	MMD reduction: Placebo: − 1.98 70 mg: − 3.60 (p < 0.001)
NCT03828539 Uwe et al. [27]	IV	EM and ≤ 2 prior classes of failed preventive treatments	6 months n = 777	Rate of discontinuation: 70 mg/140 mg: 10.6% Topiramate 100 mg: 38.9% (p < 0.001)
NCT03333109 Wang et al. EMPOwER [28]	III	EM and ≤ 2 prior classes of failed preventive treatments	3 months n = 900	MMD reduction: Placebo: − 3.1 70 mg: − 4.2 (p = 0.002) 140 mg: − 4.8 (p < 0.001)

Study

Phase

Inclusion criteria

Study period/n

Primary endpoint^a

NCT01952574

Sun et al. [16]

EM and ≤ 2 prior classes of failed preventive treatments

3 months

n = 483

MMD reduction:

Placebo: − 2.3

70 mg: − 3.4 (p = 0.021)

7 mg and 21 mg not significant

Ashina et al. [17]^b

5 years

n = 383

MMD reduction: − 5.3

NCT02066415

Tepper et al. [18]

CM and ≤ 3 prior classes of failed preventive treatments

3 months

n = 667

MMD reduction:

Placebo: − 4.2

70 mg: − 6.6 (p < 0.0001)

140 mg: − 6.6 (p < 0.0001)

NCT02174861

Tepper et al. [19]^b

12 months

n = 451

MMD reduction:

70 mg: − 8.5

140 mg: − 10.5

NCT02456740

Goadsby et al. (STRIVE) [20]

III

EM and ≤ 2 prior classes of failed preventive treatments

4-6 months

n = 955

MMD reduction:

Placebo: − 1.8

70 mg: − 3.2 (p < 0.001)

140 mg: − 3.7 (p < 0.001)

Godasby et al. [21]^b

12 months

n = 845

MMD reduction:

70 mg: − 4.2

140 mg: − 4.6

NCT02483585

Dodick et al. (ARISE) [22]

III

EM and ≤ 2 prior classes of failed preventive treatments

3 months

n = 577

MMD reduction:

Placebo: − 1.8

70 mg: − 2.9 (p < 0.001)

NCT03096834

Reuter et al. (LIBERTY) [23]

III

EM and 2-4 prior classes of failed preventive treatments

3 months

n = 246

50% or greater reduction rate of MMD:

Placebo: 14%

140 mg: 30% (p = 0.002)

Goadsby et al. [24]^b

64 weeks

n = 204

50% or greater reduction rate of MMD: 44.3%

NCT02630459

Sakai et al. [25]

EM and ≤ 2 prior classes of failed preventive treatments

4–6 months

n = 475

MMD reduction:

Placebo: 0.06

28 mg: − 1.25 (p = 0.004)

70 mg: − 2.31 (p < 0.001)

140 mg: − 1.89 (p < 0.001)

NCT03812224

Takeshima et al. [26]

III

EM and CM, and ≤ 3 classes of failed preventive treatments

4–6 months

n = 261

MMD reduction:

Placebo: − 1.98

70 mg: − 3.60 (p < 0.001)

NCT03828539

Uwe et al. [27]

EM and ≤ 2 prior classes of failed preventive treatments

6 months

n = 777

Rate of discontinuation:

70 mg/140 mg: 10.6%

Topiramate 100 mg: 38.9%

(p < 0.001)

NCT03333109

Wang et al. EMPOwER [28]

III

EM and ≤ 2 prior classes of failed preventive treatments

3 months

n = 900

MMD reduction:

Placebo: − 3.1

70 mg: − 4.2 (p = 0.002)

140 mg: − 4.8 (p < 0.001)

All erenumab treatments were given as monthly subcutaneous injections

EM episodic migraine, CM chronic migraine, MMD mean monthly migraine day

^ap Values are results compared against placebo

^bOpen-label extension study