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Table 1 Demographics and other baseline characteristics in Study 1 and Study 2 (FAS)

From: Optimal dose determination of enerisant (TS-091) for patients with narcolepsy: two randomized, double-blind, placebo-controlled trials

Variables

Study 1

Study 2

Enerisant

25 mg

Enerisant

50 mg

Enerisant

100 mg

Placebo

Total

Enerisant

5 mg

Enerisant

10 mg

Placebo

Total

(n = 12)

(n = 13)

(n = 9)

(n = 12)

(n = 46)

(n = 17)

(n = 18)

(n = 18)

(n = 53)

Age, y, mean ± SD

28.9 ± 5.7

26.1 ± 5.6

28.6 ± 4.3

25.8 ± 5.9

27.2 ± 5.5

26.9 ± 9.7

26.2 ± 8.0

29.4 ± 10.4

27.5 ± 9.3

Sex, n (%)

 Female

4 (33.3)

8 (61.5)

6 (66.7)

5 (41.7)

23 (50.0)

9 (52.9)

10 (55.6)

8 (44.4)

27 (50.9)

 Male

8 (66.7)

5 (38.5)

3 (33.3)

7 (58.3)

23 (50.0)

8 (47.1)

8 (44.4)

10 (55.6)

26 (49.1)

Country, n (%)

 Japan

-

-

-

-

-

13 (76.5)

13 (72.2)

14 (77.8)

40 (75.5)

 Korea

-

-

-

-

-

4 (23.5)

5 (27.8)

4 (22.2)

13 (24.5)

 Body weight (kg, mean ± SD)

62.76 ± 8.19

59.97 ± 11.66

62.58 ± 14.33

67.11 ± 12.86

63.07 ± 11.70

66.01 ± 14.83

62.19 ± 14.53

62.77 ± 13.91

63.61 ± 14.24

 Body mass index (kg/m2, mean ± SD)

22.83 ± 2.30

22.38 ± 2.90

23.80 ± 4.85

24.32 ± 4.50

23.28 ± 3.64

24.22 ± 4.92

23.31 ± 4.39

23.16 ± 4.37

23.55 ± 4.49

Diagnosis, n (%)

 Narcolepsy with cataplexy

6 (50.0)

7 (53.8)

6 (66.7)

7 (58.3)

26 (56.5)

-

-

-

-

 Narcolepsy without cataplexy

6 (50.0)

6 (46.2)

3 (33.3)

5 (41.7)

20 (43.5)

-

-

-

-

 Narcolepsy type 1

-

-

-

-

-

5 (29.4)

9 (50.0)

6 (33.3)

20 (37.7)

 Narcolepsy type 2

-

-

-

-

-

12 (70.6)

9 (50.5)

12 (66.7)

33 (62.3)

 Duration of disease (year, mean ± SD)

1.33 ± 2.30

1.42 ± 1.80

3.28 ± 4.06

1.64 ± 2.65

1.82 ± 2.71

2.08 ± 1.82

2.28 ± 3.37

1.85 ± 2.33

2.08 ± 2.56

 Mean SL in baseline MWT, (min, mean ± SD)

2.12 ± 1.77

3.22 ± 2.45

2.46 ± 1.54

2.64 ± 2.06

2.63 ± 2.00

5.40 ± 3.04

5.08 ± 2.49

4.56 ± 3.24

5.01 ± 2.90

 Baseline total ESS score, (mean ± SD)

19.3 ± 2.5

19.4 ± 2.6

18.0 ± 3.4

16.7 ± 4.0

18.4 ± 3.2

16.8 ± 3.6

17.8 ± 3.8

17.2 ± 2.8

17.3 ± 3.4

  1. SD standard deviation, SL sleep latency, MWT maintenance of wakefulness test, and ESS Epworth Sleepiness Scale