Table 1.
Subject demographic and clinical characteristics at baseline (safety population)
| Characteristic | Placebo (n = 96) | GEn 600 mg (n = 115) | GEn 1200 mg (n = 111) |
|---|---|---|---|
| Age, years | 49.1 (12.19) | 48.3 (12.83) | 49.5 (12.67) |
| Gender, % female | 59 | 58 | 59 |
| Race, White/Caucasian, % | 95 | 92 | 96 |
| Duration of RLS symptoms, years | 14.4 (12.85) | 13.5 (13.07) | 14.1 (12.36) |
| No previous RLS treatment, % | 61 | 67 | 65 |
| IRLS total scorea | 23.8 (4.58) | 23.1 (4.93)b | 23.2 (5.32) |
| Average daily wake time after sleep onset, minutesa | 38.7 (42.57) | 31.8 (26.71)c | 31.4 (28.48) |
| Average daily total sleep time, hoursa | 6.7 (1.20) | 6.7 (1.10)c | 6.5 (1.37) |
| MOS Sleep Scalea | |||
| Sleep quantity, hours | 6.0 (1.31) | 6.1 (1.14)b | 6.1 (1.42) |
| Sleep adequacy score | 34.8 (24.62) | 30.5 (24.08)b | 34.7 (24.86) |
| Sleep disturbance score | 51.9 (23.16) | 53.1 (20.90)b | 52.1 (22.85) |
| Daytime somnolence score | 34.8 (19.45) | 34.0 (19.44)b | 36.7 (21.97) |
| Post-Sleep Questionnairea | |||
| Overall quality of sleep | |||
| Excellent | 0 | 0e | 0d |
| Reasonable | 41 (42.7) | 40 (35.7)e | 43 (39.1)d |
| Poor | 55 (57.3) | 72 (64.3)e | 67 (60.9)d |
| Ability to function | |||
| Excellent | 8 (8.3) | 9 (8.0)e | 5 (4.5)d |
| Good | 40 (41.7) | 50 (44.6)e | 55 (50.0)d |
| Moderate | 46 (47.9) | 47 (42.0)e | 39 (35.5)d |
| Poor | 2 (2.1) | 6 (5.4)e | 11 (10.0)d |
| Number of nights with RLS symptoms | |||
| 0 nights | 1 (1.0) | 0e | 1 (0.9)d |
| 1–2 nights | 2 (2.1) | 2 (1.8)e | 1 (0.9)d |
| 3–4 nights | 10 (10.4) | 11 (9.8)e | 7 (6.4)d |
| 5–6 nights | 30 (31.3) | 34 (30.4)e | 31 (28.2)d |
| 7 nights | 53 (55.2) | 65 (58.0)e | 70 (63.6)d |
| Number of awakenings during night due to RLS symptoms | |||
| 0 times | 8 (8.3) | 19 (17.0)e | 12 (10.9)d |
| 1–2 times | 47 (49.0) | 48 (42.9)e | 55 (50.0)d |
| 3–4 times | 29 (30.2) | 34 (30.4)e | 32 (29.1)d |
| ≥ 5 times | 12 (12.5) | 11 (9.8)e | 11 (10.0)d |
| Number of hours awake per night due to RLS symptoms | |||
| 0 hours | 8 (8.3) | 19 (17.0)e | 12 (10.9)d |
| < 1 hours | 40 (41.7) | 40 (35.7)e | 52 (47.3)d |
| 1 to < 2 hours | 24 (25.0) | 35 (31.3)e | 27 (24.5)d |
| 2 to < 3 hours | 16 (16.7) | 13 (11.6)e | 12 (10.9)d |
| ≥ 3 hours | 8 (8.3) | 5 (4.5)e | 7 (6.4)d |
| ESS total score | 9.6 (4.98) | 9.7 (5.22)c | 9.0 (4.76)d |
All values are mean (SD) unless otherwise stated.
a
mITT population;
b
n = 114;
c
n = 113;
d
n = 110;
e
n = 112.
ESS, Epworth Sleepiness Scale; GEn, gabapentin enacarbil; IRLS, International Restless Legs Scale; mITT, modified intent-to-treat; MOS, Medical Outcomes Study; SD, standard deviation; RLS, Restless Legs Syndrome.