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Table 3 Secondary endpoint outcomes: ESS 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 = 11)

(n = 13)

(n = 9)

(n = 12)

(n = 16)

(n = 18)

(n = 17)

Baseline

19.3 ± 2.5

19.4 ± 2.6

18.0 ± 3.4

16.7 ± 4.0

16.8 ± 3.6

17.8 ± 3.8

17.2 ± 2.8

Week 3a

11.2 ± 5.5

11.1 ± 5.4

13.8 ± 4.8

15.2 ± 5.4

12.7 ± 7.6

14.2 ± 4.8

13.2 ± 5.4

Change from baseline to week 3a

 − 8.0 ± 7.0

 − 8.3 ± 5.8

 − 4.2 ± 6.2

 − 1.5 ± 3.5

 − 4.3 ± 6.8

 − 3.6 ± 4.6

 − 3.9 ± 5.1

Difference compared with placebo [95% CI]

 − 4.7 [− 9.4, − 0.0]

 − 4.8 [− 9.4, −  − 0.3]

 − 1.8 [− 6.6, − 3.0]

 − 0.5 [− 4.3, − 3.4]

0.5 [− 3.3, − 4.3]

p value

0.050

0.037*

0.463

0.811

0.794

  1. mean ± SD
  2. SD standard deviation, CI confidence interval, ESS, Epworth Sleepiness Scale
  3. aIncludes data from subjects who discontinued before the completion of 3 weeks of dosing