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 |