Table 2.
Distribution of post-sleep questionnaire responses at Baseline and Week 12 last observation carried forward (LOCF) (modified intent-to-treat population)
| Week 4 LOCF |
Week 8 LOCF |
Week 12 LOCF |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 96) | GEn 600 mg (n = 114) | GEn 1200 mg (n = 111) | Placebo (n = 96) | GEn 600 mg (n = 114) | GEn 1200 mg (n = 111) | Placebo (n = 96) | GEn 600 mg (n = 114) | GEn 1200 mg (n = 111) | |
| Overall quality of sleep | |||||||||
| Excellent | 2 (2.1) | 24 (21.1) | 30 (27.0) | 5 (5.2) | 24 (21.1) | 25 (22.5) | 14 (14.6) | 24 (21.1) | 30 (27.0) |
| Reasonable | 64 (66.7) | 64 (56.1) | 66 (59.5) | 57 (59.4) | 64 (56.1) | 67 (60.4) | 53 (55.2) | 72 (63.2) | 65 (58.6) |
| Poor | 30 (31.3) | 26 (22.8) | 15 (13.5) | 34 (35.4) | 26 (22.8) | 19 (17.1) | 29 (30.2) | 18 (15.8) | 16 (14.4) |
| p-valuea | 0.0011 | < 0.0001 | 0.0014 | < 0.0001 | 0.0230 | 0.0023 | |||
| Ability to function | |||||||||
| Excellent | 18 (18.8) | 35 (30.7) | 37 (33.3) | 19 (19.8) | 35 (30.7) | 44 (39.6) | 23 (24.0) | 39 (34.2) | 45 (40.5) |
| Good | 50 (52.1) | 56 (49.1) | 54 (48.6) | 49 (51.0) | 55 (48.2) | 49 (44.1) | 49 (51.0) | 57 (50.0) | 49 (44.1) |
| Moderate | 24 (25.0) | 20 (17.5) | 17 (15.3) | 25 (26.0) | 23 (20.2) | 14 (12.6) | 19 (19.8) | 16 (14.0) | 13 (11.7) |
| Poor | 4 (4.2) | 3 (2.6) | 3 (2.7) | 3 (3.1) | 1 (0.9) | 4 (3.6) | 5 (5.2) | 2 (1.8) | 4 (3.6) |
| p-valuea | 0.0334 | 0.0120 | 0.0433 | 0.0034 | 0.0366 | 0.0152 | |||
| Number of nights with RLS symptoms | |||||||||
| 0 nights | 1 (1.0) | 19 (16.7) | 28 (25.2) | 7 (7.3) | 30 (26.3) | 31 (27.9) | 13 (13.5) | 35 (30.7) | 32 (28.8) |
| 1–2 nights | 21 (21.9) | 36 (31.6) | 28 (25.2) | 27 (28.1) | 33 (28.9) | 26 (23.4) | 17 (17.7) | 33 (28.9) | 29 (26.1) |
| 3–4 nights | 24 (25.0) | 23 (20.2) | 22 (19.8) | 17 (17.7) | 21 (18.4) | 20 (18.0) | 18 (18.8) | 15 (13.2) | 20 (18.0) |
| 5–6 nights | 20 (20.8) | 12 (10.5) | 15 (13.5) | 19 (19.8) | 10 (8.8) | 13 (11.7) | 25 (26.0) | 15 (13.2) | 12 (10.8) |
| 7 nights | 30 (31.3) | 24 (21.1) | 18 (16.2) | 26 (27.1) | 20 (17.5) | 21 (18.9) | 23 (24.0) | 16 (14.0) | 18 (16.2) |
| p-valuea | 0.0002 | < 0.0001 | 0.0006 | 0.0025 | 0.0001 | 0.0006 | |||
| Number of awakenings during night due to RLS symptoms | |||||||||
| 0 times | 24 (25.0) | 55 (48.2) | 54 (48.6) | 26 (27.1) | 58 (50.9) | 55 (49.5) | 35 (36.5) | 63 (55.3) | 62 (55.9) |
| 1–2 times | 48 (50.0) | 47 (41.2) | 42 (37.8) | 51 (53.1) | 42 (36.8) | 41 (36.9) | 41 (42.7) | 42 (36.8) | 41 (36.9) |
| 3–4 times | 17 (17.7) | 8 (7.0) | 9 (8.1) | 14 (14.6) | 11 (9.6) | 13 (11.7) | 13 (13.5) | 7 (6.1) | 7 (6.3) |
| 5 or more times | 7 (7.3) | 4 (3.5) | 6 (5.4) | 5 (5.2) | 3 (2.6) | 2 (1.8) | 7 (7.3) | 2 (1.8) | 1 (0.9) |
| p-valuea | 0.0003 | 0.0019 | 0.0025 | 0.0028 | 0.0009 | 0.0004 | |||
| Number of hours awake per night due to RLS symptoms | |||||||||
| 0 hours | 24 (25.0) | 55 (48.2) | 54 (48.6) | 26 (27.1) | 58 (50.9) | 55 (49.5) | 35 (36.5) | 63 (55.3) | 62 (55.9) |
| < 1 hours | 33 (34.4) | 45 (39.5) | 39 (35.1) | 39 (40.6) | 43 (37.7) | 37 (33.3) | 42 (43.8) | 37 (32.5) | 33 (29.7) |
| 1 to < 2 hours | 29 (30.2) | 12 (10.5) | 10 (9.0) | 19 (19.8) | 8 (7.0) | 12 (10.8) | 8 (8.3) | 12 (10.5) | 8 (7.2) |
| 2 to < 3 hours | 4 (4.2) | 0 | 4 (3.6) | 6 (6.3) | 3 (2.6) | 4 (3.6) | 2 (2.1) | 0 | 5 (4.5) |
| ≥ 3 hours | 6 (6.3) | 2 (1.8) | 4 (3.6) | 6 (6.3) | 2 (1.8) | 3 (2.7) | 9 (9.4) | 2 (1.8) | 3 (2.7) |
| p-valuea | < 0.0001 | 0.0003 | < 0.0001 | 0.0011 | 0.0019 | 0.0187 | |||
Number of subjects, n (%). Questions refer to symptoms experienced over the past week.
a
p-values derived from Cochran–Mantel–Haenszel testing using equally spaced scoring and stratification by pooled site. GEn, gabapentin enacarbil.