Table 1 Baseline characteristics of the overall population and subgroups of interest by dose received during the DBTP

Episodic migraine

Placebo

(N = 315)

70 mg

(N = 305)

140 mg

(N = 312)

Placebo

(N = 191)

70 mg

(N = 179)

140 mg

(N = 192)

Placebo

(N = 124)

70 mg

(N = 126)

140 mg

(N = 120)

Demographics

Age, years (range)

41.3 ± 11.2

(18–65)

41.2 ± 11.2

(18–63)

40.4 ± 11.1

(19–65)

43.3 ± 10.9

(18–65)

43.8 ± 11

(18–63)

42 ± 10.7

(19–65)

38.4 ± 11

(18–64)

37.5 ± 10.6

(19–63)

37.9 ± 11.4

(19–62)

Female, n (%)

271 (86.0)

261 (85.6)

266 (85.3)

164 (85.9)

152 (84.9)

169 (88)

107 (86.3)

109 (86.5)

97 (80.8)

Caucasian, n (%)

274 (87.0)

274 (89.8)

288 (92.3)

180 (94.2)

173 (96.6)

184 (95.8)

94 (75.8)

101 (80.2)

104 (86.7)

Baseline characteristics

Monthly migraine days

8.3 ± 2.5

8.3 ± 2.5

8.3 ± 2.5

8.5 ± 2.5

8.4 ± 2.5

8.5 ± 2.4

7.9 ± 2.5

8.0 ± 2.3

8.1 ± 2.5

Monthly headache days

9.3 ± 2.6

9.0 ± 2.6

9.3 ± 2.5

9.3 ± 2.6

9.0 ± 2.6

9.3 ± 2.5

9.3 ± 2.6

9.0 ± 2.6

9.2 ± 2.6

Monthly migraine-specific medication days

3.5 ± 3.4

3.3 ± 3.4

3.5 ± 3.5

5.7 ± 2.6

5.7 ± 2.5

5.7 ± 2.7

0

0

0

Age at migraine onset

21.2 ± 10.1

21.2 ± 11

20.7 ± 9.9

20.6 ± 10.2

21.5 ± 11.4

21.2 ± 9.8

22.0 ± 10

20.7 ± 10.5

20.0 ± 10.2

Disease duration, years

20.2 ± 12.2

20.1 ± 12.2

19.8 ± 12.3

22.7 ± 11.9

22.4 ± 12.1

20.9 ± 12.2

16.4 ± 11.5

16.8 ± 11.5

18.0 ± 12.3

Acute headache medication use, n (%)

Any

315 (100)

305 (100)

312 (100)

191 (100)

179 (100)

192 (100)

124 (100.0)

126 (100.0)

120 (100.0)

Migraine-specific

191 (60.6)

179 (58.7)

192 (61.5)

191 (100)

179 (100)

192 (100)

0 (0)

0 (0)

0 (0)

Non-migraine-specific

244 (77.5)

242 (79.3)

256 (82.1)

120 (62.8)

116 (64.8)

136 (70.8)

124 (100.0)

126 (100.0)

120 (100.0)

Migraine-preventive medication use, n (%)

Naïve

174 (55.2)

164 (53.8)

184 (59.0)

84 (44)

73 (40.8)

87 (45.3)

90 (72.6)

91 (72.2)

97 (80.8)

Previous

131 (41.6)

132 (43.3)

120 (38.5)

100 (52.4)

100 (55.9)

100 (52.1)

31 (25.0)

32 (25.4)

20 (16.7)

History of treatment failure of preventive medication*

127 (40.3)

126 (41.3)

112 (35.9)

98 (54.7)

98 (54.7)

92 (47.9)

28 (22.6)

28 (22.2)

20 (16.7)

History of migraine with aura, n (%)

160 (50.8)

162 (53.1)

157 (50.3)

82 (42.9)

82 (45.8)

84 (43.8)

78 (62.9)

80 (63.5)

73 (60.8)

Chronic migraine

Placebo

(N = 282)

70 mg

(N = 191)

140 mg

(N = 188)

Placebo

(N = 225)

70 mg

(N = 143)

140 mg

(N = 149)

Placebo

(N = 57)

70 mg

(N = 48)

140 mg

(N = 39)

Demographics

Age, years (range)

42.2 ± 11.3 (18–66)

41.4 ± 11.3 (18–64)

43.1 ± 11 (18–64)

43.4 ± 11.1 (18–66)

42.5 ± 11 (18–64)

44.4 ± 10.3 (18–64)

37.7 ± 11 (18–64)

38.1 ± 11.7 (18–58)

38.3 ± 12.3 (20–58)

Female, n (%)

223 (79.1)

166 (86.9)

158 (84)

175 (77.8)

126 (88.1)

134 (89.9)

48 (84.2)

40 (83.3)

24 (61.5)

Caucasian, n (%)

264 (93.6)

176 (92.1)

182 (96.8)

215 (95.6)

134 (93.7)

146 (98)

49 (86)

42 (87.5)

36 (92.3)

Baseline characteristics

Monthly migraine days

18.2 ± 4.7

17.9 ± 4.4

17.7 ± 4.6

18.2 ± 4.6

18.1 ± 4.4

17.7 ± 4.3

18.1 ± 5.3

17.1 ± 4.4

17.5 ± 5.9

Monthly headache days

21.1 ± 3.9

20.5 ± 3.8

20.7 ± 3.8

20.9 ± 3.8

20.6 ± 3.8

20.3 ± 3.7

21.8 ± 4.3

20.3 ± 4

21.9 ± 3.8

Monthly migraine-specific medication days

9.6 ± 7.6

8.8 ± 7.2

9.8 ± 7.0

12.0 ± 6.5

11.7 ± 5.8

12.3 ± 5.5

0

0

0

Age at migraine onset

20.3 ± 10.0

21.1 ± 10.5

21.5 ± 10.7

20.7 ± 10.1

19.9 ± 10.2

21.1 ± 10.8

18.8 ± 9.4

24.7 ± 10.9

23.2 ± 10.4

Disease duration, years

22.4 ± 12.6

20.7 ± 12.8

22.1 ± 11.8

23.1 ± 12.8

23.0 ± 12.9

23.8 ± 11.2

19.4 ± 11.7

13.9 ± 10.2

15.6 ± 11.9

Acute headache medication use, n (%)

Any

282 (100)

191 (100)

188 (100)

225 (100)

143 (100)

149 (100)

57 (100)

48 (100)

39 (100)

Migraine-specific

225 (79.8)

143 (74.9)

149 (79.3)

225 (100)

143 (100)

149 (100)

0 (0)

0 (0)

0 (0)

Non-migraine-specific

246 (87.2)

167 (87.4)

161 (85.6)

189 (84)

119 (83.2)

122 (81.9)

57 (100)

48 (100)

39 (100)

Migraine-preventive medication use, n (%)

Naïve

67 (23.8)

53 (27.7)

54 (28.7)

41 (18.2)

31 (21.7)

31 (20.8)

26 (45.6)

22 (45.8)

23 (59.0)

Previous

215 (76.2)

138 (72.3)

134 (71.3)

184 (81.8)

112 (78.3)

118 (79.2)

31 (54.4)

26 (54.2)

16 (41.0)

History of treatment failure of preventive medication^a

198 (70.2)

127 (66.5)

124 (66)

170 (75.6)

105 (93.8)

111 (94.1)

28 (49.1)

22 (45.8)

13 (33.3)

History of migraine with aura, n (%)

122 (43.3)

81 (42.4)

70 (37.2)

93 (41.3)

58 (40.6)

61 (40.9)

29 (50.9)

23 (47.9)

9 (23.1)