. 2022 Mar 8;12(4):e2542. doi: 10.1002/brb3.2542

TABLE 1.

Basic characteristics of included studies

Included studies	Research type	Follow‐up time	Number of cases (intervening measure)	Mean age (mean value ± SD/median)	Sex (F/M)
Dodick et al., 2018	RCT Phase III NCT02483585	12 weeks	286 (Erenumab 70 mg) 291 (Placebo)	42 ± 11 42 ± 12	245/41 247/44
Diener et al., 2010	RCT Phase II NCT00751803	1 week	64 (BI44370TA 50 mg) 65 (BI44370TA 200 mg) 73 (BI44370TA 400 mg) 69 (Eletriptan 40 mg) 70 (Placebo)	42.8 ± 11.7 41.2 ± 9.7 41.1 ± 10.0 37.9 ± 10.1 38.2 ± 10.3	54/10 53/12 55/18 61/8 61/9
Marcus et al., 2014	RCT Phase II NCT01430442	11 weeks	85 (BMS‐927711 10 mg) 68 (BMS‐927711 25 mg) 91 (BMS‐927711 75 mg) 90 (BMS‐927711 150 mg) 121 (BMS‐927711 300 mg) 92 (BMS‐927711 600 mg) 109 (Sumatriptan 100 mg) 229 (Placebo)	41.1 ± 10.36 36.5 ± 11.92 38.5 ± 11.87 39.2 ± 11.26 41.9 ± 11.46 39.3 ± 13.01 40.6 ± 10.47 37.9 ± 11.36	67/18 61/7 81/10 63/27 101/20 76/16 91/18 196/33
Olesen et al., 2004	RCT	24 h	1 (BIBN4096BS 0.25 mg) 4 (BIBN4096BS 0.5 mg) 20 (BIBN4096BS 1 mg) 32 (BIBN4096BS 2.5 mg) 16 (BIBN4096BS 5 mg) 12 (BIBN4096BS 10 mg) 41 (Placebo)	43 42 49 45 52 47 47	1/0 3/1 18/2 29/3 13/3 7/5 29/12
Goadsby et al., 2017	RCT NCT02456740	6 months	317 (Erenumab 70 mg) 319 (Erenumab 140 mg) 319 (Placebo)	41.1 ± 11.3 40.4 ± 11.1 41.3 ± 11.2	268/49 272/47 274/45
Reuter et al., 2018	RCT Phase IIIb NCT03096834	12 weeks	121 (Erenumab 140 mg) 125 (Placebo)	44.6 ± 10.5 44.2 ± 10.6	97/24 103/22
Dodick, Lipton, Ailani et al., 2019	RCT Phase IIb NCT02275117	49 weeks	130 (Eptinezumab 10 mg) 122 (Eptinezumab 30 mg) 122 (Eptinezumab 100 mg) 121 (Eptinezumab 300 mg) 121 (Placebo)	36.4 ± 10.3 35.7 ± 9.4 36.7 ± 9.4 37.2 ± 10.0 37.2 ± 9.2	113/27 111/9 104/18 98/23 109/12
Tepper et al., 2017	RCT Phase II NCT02066415	12 weeks	191 (Erenumab 70 mg) 190 (Erenumab 140 mg) 286 (Placebo)	41.4 ± 11.3 42.9 ± 11.1 42.1 ± 11.3	166/25 160/30 226/60
Silberstein et al., 2017	RCT Phase II NCT02621931	16 weeks	376 (Fremanezumab quarterly) 379 (Fremanezumab monthly) 375 (Placebo)	42.0 ± 12.4 40.6 ± 12.0 41.4 ± 12.0	331/45 330/49 330/45
Voss et al., 2016	RCT Phase IIb NCT01613248	48 h	107 (Ubrogepant 1 mg) 108 (Ubrogepant 10 mg) 104 (Ubrogepant 25 mg) 106 (Ubrogepant 50 mg) 102 (Ubrogepant 100 mg) 113 (Placebo)	39.6 ± 10.7 41.1 ± 10.9 41.4 ± 11.5 40.7 ± 12.3 41.9 ± 11.0 40.5 ± 11.7	95/12 92/16 91/13 92/14 90/12 99/14
Hewitt, Aurora et al., 2011	RCT NCT00758836	5 days	145 (Telcagepant +Ibuprofen) 133 (Telcagepant +Acetaminophen) 138 (Telcagepant) 147 (Placebo)	39.2 ± 11.7 42.3 ± 12.7 39.3 ± 11.6 41.9 ± 12.0	123/22 118/15 119/19 130/17
Ho et al., 2008	RCT Phase II	14 days	14 (MK‐0974 25 mg) 15 (MK‐0974 50 mg) 16 (MK‐0974 100 mg) 12 (MK‐0974 200 mg) 39 (MK‐0974 300 mg) 45 (MK‐0974 400 mg) 40 (MK‐0974 600 mg) 34 (Rizatriptan 10 mg) 115 (Placebo)	43 41.5 40.9 34.3 40.5 40.1 44.5 40.2 42.2	11/3 14/1 14/2 9/3 34/5 42/3 36/4 28/6 104/11
Hewitt, Martin et al., 2011	RCT Phase II NCT00712725	14 days	33 (MK‐3207 2.5 mg) 47 (MK‐3207 5 mg) 67 (MK‐3207 10 mg) 67 (MK‐3207 20 mg) 68 (MK‐3207 50 mg) 62 (MK‐3207 100 mg) 63 (MK‐3207 200 mg) 140 (Placebo)	43.3 ± 10.5 43.4 ± 11.1 44.1 ± 10.0 44.1 ± 11.3 42.2 ± 10.8 42.4 ± 10.9 40.5 ± 10.7 42.1 ± 11.2	27/6 40/7 62/5 54/13 62/6 52/10 54/9 125/15
Ho et al., 2010	RCT Phase III NCT00483704	14 days	573 (Telcagepant 140 mg) 549 (Telcagepant 280 mg) 555 (Placebo)	43.4 ± 11.7 42.4 ± 11.5 42.5 ± 11.6	490/83 471/78 463/92
Connor et al., 2009	RCT Phase III NCT00432237	14 days	177 (Telcagepant 50 mg) 381 (Telcagepant 150 mg) 371 (Telcagepant 300 mg) 365 (placebo)	41.4 ± 11.3 41.6 ± 11.0 41.8 ± 11.6 41.9 ± 11.9	156/21 329/52 320/51 318/47
Sun et al., 2016	RCT Phase II NCT01952574	256 weeks	108 (AMG 334 7 mg) 108 (AMG 334 21 mg) 107 (AMG 334 70 mg) 160 (placebo)	40.3 ± 10.9 39.9 ± 12.3 42.6 ± 9.9 41.4 ± 10.0	88/20 87/21 82/25 132/28
Dodick, Lipton, Silberstein et al., 2019	RCT NCT02828020	24 h	466 (Ubrogepant 50 mg) 485 (Ubrogepant 100 mg) 485 (Placebo)	40.1 ± 11.7 40.6 ± 12.0 40.9 ± 11.7	418/48 418/67 430/55
Lipton, Croop et al., 2019	RCT NCT03235479	8 h	582 (Rimegepant) 580 (Placebo)	N/A N/A	N/A N/A
Lipton, Dodick et al., 2019	RCT Phase III NCT03237845	7 days	537 (Rimegepant) 535 (Placebo)	40.2 ± 11.9 40.9 ± 12.1	479/58 472/63
Lipton et al., 2018	RCT Phase III NCT02867709	48 h	478 (Ubrogepant 25 mg) 488 (Ubrogepant 50 mg) 499 (Placebo)	41.6 ± 12.4 41.2 ± 12.5 41.7 ± 12.1	431/47 444/44 442/57
Croop et al., 2019	RCT Phase III NCT03461757	80 days	669 (Rimegepant 75 mg) 682 (Placebo)	40.3 ± 12.1 40.0 ± 11.9	568/101 579/103
Goadsby et al., 2019	RCT Phase IIb/III NCT02848326	12 weeks	93 (Atogepant 10 mg QD) 183 (Atogepant 30 mg QD) 86 (Atogepant 30 mg BID) 186 (Atogepant 60 mg QD) 91 (Atogepant 60 mg BID) 186 (Placebo)	39.4 ± 12.4 41.0 ± 13.6 38.5 ± 11.2 40.4 ± 11.7 39.7 ± 11.9 40.5 ± 11.7	82/11 166/17 73/13 156/30 83/8 154/32
Skljarevski et al., 2018	RCT Phase III NCT02614196	6 months	231 (Galcanezumab120 mg) 223 (Galcanezumab240 mg) 461 (Placebo)	40.9 ± 11.2 41.9 ± 10.8 42.3 ± 11.3	197/34 191/32 393/68
Detke et al., 2018	RCT Phase III NCT02614261	3 months	278 (Galcanezumab120 mg) 277 (Galcanezumab240 mg) 558 (Placebo)	39.7 ± 11.9 41.1 ± 12.4 41.6 ± 12.1	237/41 226/51 483/75
Stauffer et al., 2018	RCT Phase III NCT02614183	6 months	213 (Galcanezumab120 mg) 212 (Galcanezumab240 mg) 433 (Placebo)	40.9 ± 11.9 39.1 ± 11.5 41.3 ± 11.4	181/97 175/102 362/196
Mulleners et al., 2020	RCT Phase IIIb NCT03559257	3 months	232 (Galcanezumab120 mg) 230 (Placebo)	45.9 ± 11.3 45.7 ± 12.3	195/37 202/28

Included studies

Research type

Follow‐up time

Number of cases (intervening measure)

Mean age (mean value ± SD/median)

Sex (F/M)

Dodick et al., 2018

RCT Phase III

NCT02483585

12 weeks

286 (Erenumab 70 mg)

291 (Placebo)

42 ± 11

42 ± 12

245/41

247/44

Diener et al., 2010

RCT Phase II

NCT00751803

1 week

64 (BI44370TA 50 mg)

65 (BI44370TA 200 mg)

73 (BI44370TA 400 mg)

69 (Eletriptan 40 mg)

70 (Placebo)

42.8 ± 11.7

41.2 ± 9.7

41.1 ± 10.0

37.9 ± 10.1

38.2 ± 10.3

54/10

53/12

55/18

61/8

61/9

Marcus et al., 2014

RCT Phase II

NCT01430442

11 weeks

85 (BMS‐927711 10 mg)

68 (BMS‐927711 25 mg)

91 (BMS‐927711 75 mg)

90 (BMS‐927711 150 mg)

121 (BMS‐927711 300 mg)

92 (BMS‐927711 600 mg)

109 (Sumatriptan 100 mg)

229 (Placebo)

41.1 ± 10.36

36.5 ± 11.92

38.5 ± 11.87

39.2 ± 11.26

41.9 ± 11.46

39.3 ± 13.01

40.6 ± 10.47

37.9 ± 11.36

67/18

61/7

81/10

63/27

101/20

76/16

91/18

196/33

Olesen et al., 2004

RCT

24 h

1 (BIBN4096BS 0.25 mg)

4 (BIBN4096BS 0.5 mg)

20 (BIBN4096BS 1 mg)

32 (BIBN4096BS 2.5 mg)

16 (BIBN4096BS 5 mg)

12 (BIBN4096BS 10 mg)

41 (Placebo)

1/0

3/1

18/2

29/3

13/3

7/5

29/12

Goadsby et al., 2017

RCT

NCT02456740

6 months

317 (Erenumab 70 mg)

319 (Erenumab 140 mg)

319 (Placebo)

41.1 ± 11.3

40.4 ± 11.1

41.3 ± 11.2

268/49

272/47

274/45

Reuter et al., 2018

RCT Phase IIIb

NCT03096834

12 weeks

121 (Erenumab 140 mg)

125 (Placebo)

44.6 ± 10.5

44.2 ± 10.6

97/24

103/22

Dodick, Lipton, Ailani et al., 2019

RCT Phase IIb

NCT02275117

49 weeks

130 (Eptinezumab 10 mg)

122 (Eptinezumab 30 mg)

122 (Eptinezumab 100 mg)

121 (Eptinezumab 300 mg)

121 (Placebo)

36.4 ± 10.3

35.7 ± 9.4

36.7 ± 9.4

37.2 ± 10.0

37.2 ± 9.2

113/27

111/9

104/18

98/23

109/12

Tepper et al., 2017

RCT Phase II

NCT02066415

12 weeks

191 (Erenumab 70 mg)

190 (Erenumab 140 mg)

286 (Placebo)

41.4 ± 11.3

42.9 ± 11.1

42.1 ± 11.3

166/25

160/30

226/60

Silberstein et al., 2017

RCT Phase II

NCT02621931

16 weeks

376 (Fremanezumab quarterly)

379 (Fremanezumab monthly)

375 (Placebo)

42.0 ± 12.4

40.6 ± 12.0

41.4 ± 12.0

331/45

330/49

330/45

Voss et al., 2016

RCT Phase IIb

NCT01613248

48 h

107 (Ubrogepant 1 mg)

108 (Ubrogepant 10 mg)

104 (Ubrogepant 25 mg)

106 (Ubrogepant 50 mg)

102 (Ubrogepant 100 mg)

113 (Placebo)

39.6 ± 10.7

41.1 ± 10.9

41.4 ± 11.5

40.7 ± 12.3

41.9 ± 11.0

40.5 ± 11.7

95/12

92/16

91/13

92/14

90/12

99/14

Hewitt, Aurora et al., 2011

RCT

NCT00758836

5 days

145 (Telcagepant +Ibuprofen)

133 (Telcagepant +Acetaminophen)

138 (Telcagepant)

147 (Placebo)

39.2 ± 11.7

42.3 ± 12.7

39.3 ± 11.6

41.9 ± 12.0

123/22

118/15

119/19

130/17

Ho et al., 2008

RCT Phase II

14 days

14 (MK‐0974 25 mg)

15 (MK‐0974 50 mg)

16 (MK‐0974 100 mg)

12 (MK‐0974 200 mg)

39 (MK‐0974 300 mg)

45 (MK‐0974 400 mg)

40 (MK‐0974 600 mg)

34 (Rizatriptan 10 mg)

115 (Placebo)

41.5

40.9

34.3

40.5

40.1

44.5

40.2

42.2

11/3

14/1

14/2

9/3

34/5

42/3

36/4

28/6

104/11

Hewitt, Martin et al., 2011

RCT Phase II

NCT00712725

14 days

33 (MK‐3207 2.5 mg)

47 (MK‐3207 5 mg)

67 (MK‐3207 10 mg)

67 (MK‐3207 20 mg)

68 (MK‐3207 50 mg)

62 (MK‐3207 100 mg)

63 (MK‐3207 200 mg)

140 (Placebo)

43.3 ± 10.5

43.4 ± 11.1

44.1 ± 10.0

44.1 ± 11.3

42.2 ± 10.8

42.4 ± 10.9

40.5 ± 10.7

42.1 ± 11.2

27/6

40/7

62/5

54/13

62/6

52/10

54/9

125/15

Ho et al., 2010

RCT Phase III

NCT00483704

14 days

573 (Telcagepant 140 mg)

549 (Telcagepant 280 mg)

555 (Placebo)

43.4 ± 11.7

42.4 ± 11.5

42.5 ± 11.6

490/83

471/78

463/92

Connor et al., 2009

RCT Phase III

NCT00432237

14 days

177 (Telcagepant 50 mg)

381 (Telcagepant 150 mg)

371 (Telcagepant 300 mg)

365 (placebo)

41.4 ± 11.3

41.6 ± 11.0

41.8 ± 11.6

41.9 ± 11.9

156/21

329/52

320/51

318/47

Sun et al., 2016

RCT Phase II

NCT01952574

256 weeks

108 (AMG 334 7 mg)

108 (AMG 334 21 mg)

107 (AMG 334 70 mg)

160 (placebo)

40.3 ± 10.9

39.9 ± 12.3

42.6 ± 9.9

41.4 ± 10.0

88/20

87/21

82/25

132/28

Dodick, Lipton, Silberstein et al., 2019

RCT

NCT02828020

24 h

466 (Ubrogepant 50 mg)

485 (Ubrogepant 100 mg)

485 (Placebo)

40.1 ± 11.7

40.6 ± 12.0

40.9 ± 11.7

418/48

418/67

430/55

Lipton, Croop et al., 2019

RCT

NCT03235479

8 h

582 (Rimegepant)

580 (Placebo)

N/A

Lipton, Dodick et al., 2019

RCT Phase III

NCT03237845

7 days

537 (Rimegepant)

535 (Placebo)

40.2 ± 11.9

40.9 ± 12.1

479/58

472/63

Lipton et al., 2018

RCT Phase III

NCT02867709

48 h

478 (Ubrogepant 25 mg)

488 (Ubrogepant 50 mg)

499 (Placebo)

41.6 ± 12.4

41.2 ± 12.5

41.7 ± 12.1

431/47

444/44

442/57

Croop et al., 2019

RCT Phase III

NCT03461757

80 days

669 (Rimegepant 75 mg)

682 (Placebo)

40.3 ± 12.1

40.0 ± 11.9

568/101

579/103

Goadsby et al., 2019

RCT Phase IIb/III

NCT02848326

12 weeks

93 (Atogepant 10 mg QD)

183 (Atogepant 30 mg QD)

86 (Atogepant 30 mg BID)

186 (Atogepant 60 mg QD)

91 (Atogepant 60 mg BID)

186 (Placebo)

39.4 ± 12.4

41.0 ± 13.6

38.5 ± 11.2

40.4 ± 11.7

39.7 ± 11.9

40.5 ± 11.7

82/11

166/17

73/13

156/30

83/8

154/32

Skljarevski et al., 2018

RCT Phase III

NCT02614196

6 months

231 (Galcanezumab120 mg)

223 (Galcanezumab240 mg)

461 (Placebo)

40.9 ± 11.2

41.9 ± 10.8

42.3 ± 11.3

197/34

191/32

393/68

Detke et al., 2018

RCT Phase III

NCT02614261

3 months

278 (Galcanezumab120 mg)

277 (Galcanezumab240 mg)

558 (Placebo)

39.7 ± 11.9

41.1 ± 12.4

41.6 ± 12.1

237/41

226/51

483/75

Stauffer et al., 2018

RCT Phase III

NCT02614183

6 months

213 (Galcanezumab120 mg)

212 (Galcanezumab240 mg)

433 (Placebo)

40.9 ± 11.9

39.1 ± 11.5

41.3 ± 11.4

181/97

175/102

362/196

Mulleners et al., 2020

RCT Phase IIIb

NCT03559257

3 months

232 (Galcanezumab120 mg)

230 (Placebo)

45.9 ± 11.3

45.7 ± 12.3

195/37

202/28