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Table 2 Characteristics of dosing by study completion status and number of doses administered

From: Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial

Completion status

Total number of lasmiditan doses

Totalb

Lasmiditan dosing summarya

Completed

n = 321

Discontinued due to AE

n = 22

Discontinued due to lack of efficacy

n = 36

 < 10

n = 156

 ≥ 10

n = 289

N = 445

Total number of lasmiditan doses administered

24.0 (17.45)

6.2 (7.26)

8.0 (7.30)

4.3 (2.51)

27.7 (15.93)

19.5 (17.09)

Lasmiditan doses per month

1.8 (1.34)

1.4 (0.80)

1.6 (1.04)

0.7 (0.56)

2.2 (1.24)

1.7 (1.28)

Last dose in double-blind period, n (%)c

 Placebo

53 (80.3)

5 (7.6)

8 (12.1)

40 (50.0)

40 (50.0)

80 (100)

 50

61 (80.3)

6 (7.9)

9 (11.8)

30 (34.5)

57 (65.5)

87 (100)

 100

106 (85.5)

5 (4.0)

13 (10.5)

47 (32.2)

99 (67.8)

146 (100)

 200

101 (89.4)

6 (5.3)

6 (5.3)

39 (29.5)

93 (70.5)

132 (100)

Modal dose, n (%)d

 50 mg

52 (16.2)

0 (0)

3 (8.3)

11 (7.1)

46 (15.9)

57 (12.8)

 100 mg

205 (63.9)

18 (81.8)

20 (55.6)

114 (73.1)

179 (61.9)

293 (65.8)

 200 mg

64 (19.9)

4 (18.2)

13 (36.1)

30 (19.2)

64 (22.1)

94 (21.1)

 

Completion status

Lasmiditan doses

Totalb

Demographics and clinical characteristicsa

Completed

n = 321

Discontinued due to AE

n = 22

Discontinued due to lack of efficacy

n = 36

 < 10

n = 156

 ≥ 10

n = 289

N = 445

Age, years

43.0 (12.0)

38.7 (10.3)

45.1 (9.9)

40.2 (11.8)

43.8 (11.7)

42.5 (11.9)

Sex, female, n (%)

271 (84.4)

19 (86.4)

33 (91.7)

136 (87.2)

247 (85.5)

383 (86.1)

MIDAS Total Score

 Baseline (V1)

28.4 (17.73)

34.4 (34.67)

39.5 (33.32)

25.5 (12.72)

29.1 (18.73)

28.4 (17.73)

 Last Visit (V11 EoS)

15.3 (21.64)

NA

NA

7.9 (9.18)

17.2 (23.41)

15.3 (21.64)

MIDAS Headache Days

 Baseline (V1)

16.5 (9.92)

20.5 (8.53)

18.9 (8.75)

15.4 (7.97)

16.8 (10.34)

16.5 (9.92)

 Last Visit (V11 EoS)

10.6 (11.90)

NA

NA

6.6 (9.01)

11.6 (12.34)

10.6 (11.90)

MIDAS Average Pain Severity

 Baseline (V1)

7.5 (1.67)

7.5 (1.62)

7.3 (1.40)

7.3 (1.73)

7.5 (1.65)

7.5 (1.67)

 Last Visit (V11 EoS)

6.2 (2.17)

NA

NA

5.2 (2.72)

6.4 (1.95)

6.2 (2.17)

MSQ Total Score

 OLE baseline (V6)

61.9 (16.31)

59.1 (18.47)

58.3 (17.71)

64.6 (15.86)

61.2 (16.39)

61.9 (16.31)

 Last Visit (V11 EoS or ET)e

73.2 (18.10)

66.9 (14.76)

58.8 (19.68)

81.7 (17.65)

70.9 (17.58)

73.2 (18.10)

MSQ Role Function Restrictive

 OLE baseline (V6)

55.3 (16.91)

52.9 (19.13)

50.6 (18.80)

57.8 (16.02)

54.6 (17.10)

55.3 (16.91)

 Last Visit (V11 EoS or ET)e

68.0 (19.65)

59.7 (15.12)

52.2 (18.24)

77.8 (20.28)

65.5 (18.70)

68.0 (19.65)

MSQ Role Function Preventive

 OLE baseline (V6)

69.1 (19.21)

66.8 (20.08)

65.6 (18.39)

71.4 (19.64)

68.5 (19.09)

69.1 (19.21)

 Last Visit (V11 EoS or ET)e

78.7 (17.89)

76.3 (13.83)

66.5 (23.05)

86.2 (15.18)

76.8 (18.06)

78.7 (17.89)

MSQ Emotional Function

 OLE baseline (V6)

68.1 (23.01)

63.2 (27.34)

66.5 (20.69)

71.6 (22.21)

67.2 (23.16)

68.1 (23.01)

 Last Visit (V11 EoS or ET)e

77.9 (21.37)

71.2 (25.73)

63.7 (24.45)

84.8 (20.36)

76.2 (21.3)

77.9 (21.37)

 mTOQ-6

Baselinef (V2)

4.5 (2.54)

5.0 (2.45)

4.0 (2.89)

4.6 (2.47)

4.6 (2.59)

4.6 (2.55)

PGIC-MHC, n (%) (V11 EoS)

 Very much better

46 (14.3)

1 (4.6)

0

15 (9.6)

35 (12.1)

50 (11.2)

 Much better

77 (24.0)

0

0

18 (11.5)

65 (22.5)

83 (18.7)

 A little better

83 (25.9)

3 (13.6)

1 (2.8)

23 (14.7)

69 (23.9)

92 (20.7)

 No change

98 (30.5)

13 (59.1)

26 (72.2)

62 (39.7)

95 (32.9)

157 (35.3)

 A little worse

10 (3.1)

3 (13.6)

4 (11.1)

11 (7.1)

9 (3.1)

20 (4.5)

 Much worse

3 (0.9)

0

1 (2.8)

0

4 (1.4)

4 (0.9)

 Very much worse

1 (0.3)

0

0

0

1 (0.4)

1 (0.2)

  1. AE adverse event, EoS end of study, ET early termination, MIDAS Migraine Disability Assessment, MSQ Migraine-Specific Quality of Life Questionnaire, mTOQ-6 Migraine Treatment Optimization Questionnaire, NA not available, PGIC-MHC Patient Global Impression of Change – Migraine Headache Condition, V visit
  2. aPer study design, visits 1 and 2 represent baseline visits in the double-blind portion of the study whereas visit 6 corresponds to the OLE baseline visit. Mean (SD) shown unless otherwise indicated
  3. bThe total column pertains to the lasmiditan dose categories only, as not all reasons for discontinuation were studied herein under ‘completion status’. The total population includes 4 participants who did not administer 100 mg during the OLE. Data are summarized based on non-missing values at each corresponding time point
  4. cThe proportion of patients taking each of the treatments as their last dose in the double-blind study was calculated using the number of patients in each treatment group as the denominator
  5. dFor modal dose, the proportion of patients with each dose level as a modal dose was calculated using the number of patients in each completion status or dose number cohort as the denominator
  6. eET data shown for the last visit for patients who discontinued due to AE or lack of efficacy
  7. fData are for current triptan users only
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The Journal of Headache and Pain

ISSN: 1129-2377

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