Table 1 Demographics and baseline characteristics (Safety Set)
Characteristic | Placebo (n = 40) | Rotigotine low dose (n = 41) | Rotigotine high dose (n = 41) |
|---|---|---|---|
Male, n (%) | 22 (55.0) | 27 (65.9) | 27 (65.9) |
Age, mean ± SD, years | 69.0 ± 11.7 | 68.1 ± 10.5 | 70.2 ± 8.0 |
Disease stage, n (%) | |||
Early (i.e., not taking levodopa) | 8 (20.0) | 9 (22.0) | 9 (22.0) |
Advanced (i.e., taking levodopa) | 32 (80.0) | 32 (78.0) | 32 (78.0) |
With motor fluctuations | 18 (45.0) | 17 (41.5) | 16 (39.0) |
Without motor fluctuations | 14 (35.0) | 15 (36.6) | 16 (39.0) |
Time since PD diagnosis, mean ± SD, years | 3.7 ± 3.7 | 4.9 ± 4.0 | 4.8 ± 4.3 |
Baseline daily levodopa dose, n (%) | |||
<600 mg/day | 19 (47.5) | 18 (43.9) | 20 (48.8) |
≥600 mg/day | 13 (32.5) | 14 (34.1) | 12 (29.3) |
Cardinal signs, n (%) | |||
Bradykinesia | 40 (100) | 41 (100) | 41 (100) |
Rigidity | 35 (87.5) | 37 (90.2) | 40 (97.6) |
Resting tremor | 28 (70.0) | 26 (63.4) | 33 (80.5) |
Postural instability | 25 (62.5) | 31 (75.6) | 24 (58.5) |
Hoehn and Yahr stage, n (%) | |||
0 (no signs of disease) | 0 | 0 | 0 |
1 (unilateral disease) | 14 (35.0) | 4 (9.8) | 5 (12.2) |
2 (bilateral disease without impairment of balance) | 14 (35.0) | 13 (31.7) | 14 (34.1) |
3 (mild to moderate bilateral disease) | 11 (27.5) | 20 (48.8) | 20 (48.8) |
4 (severe disability) | 1 (2.5) | 4 (9.8) | 2 (4.9) |
5 (wheelchair bound or bedridden unless aided) | 0 | 0 | 0 |
Depression at baseline, n (%) | |||
No/minimal depressiona | 21 (52.5) | 23 (56.1) | 21 (51.2) |
At least mild depressionb | 19 (47.5) | 18 (43.9) | 20 (48.8) |
UPDRS II + III total score, mean ± SD (0–160)c | 40.3 ± 19.1 | 44.4 ± 14.3 | 39.6 ± 12.4 |
AS as rated by the patient, mean ± SD (0–42)c | 19.7 ± 3.8 | 20.1 ± 4.4 | 20.2 ± 4.8 |