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Table 2 Primary endpoint outcomes: MWT changes from baseline in Study 1 and Study 2

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

Group

Study 1

Study 2

Enerisant

25 mg

Enerisant

50 mg

Enerisant

100 mg

Placebo

Enerisant

5 mg

Enerisant

10 mg

Placebo

(n = 4)

(n = 10)

(n = 7)

(n = 11)

(n = 14)

(n = 18)

(n = 16)

SL at baseline (min)

2.12 ± 1.77

3.22 ± 2.45

2.46 ± 1.54

2.64 ± 2.06

5.40 ± 3.04

5.08 ± 2.49

4.56 ± 3.24

SL at week 3 (min)

3.50 ± 4.69

3.80 ± 4.52

2.53 ± 1.85

1.65 ± 1.98

5.43 ± 4.41

5.74 ± 4.73

4.84 ± 5.20

Change from baseline to week 3 (min)

0.53 ± 2.75

0.33 ± 3.72

 − 0.16 ± 2.73

 − 0.88 ± 2.40

0.73 ± 3.42

0.66 ± 3.44

0.22 ± 4.90

Difference compared with placebo [95% CI]

1.54 [− 2.00, − 5.08]

1.50 [− 1.19, − 4.18]

0.77 [− 2.16, − 3.70]

-

0.43 [− 2.45, − 3.31]

0.41 [− 2.30, − 3.13]

p value

0.380

0.263

0.594

0.765

0.761

  1. mean ± SD
  2. CI confidence interval, SD standard deviation, SL sleep latency, MWT maintenance of wakefulness test