Demographics and baseline characteristics of the intent to treat population (n=83) with mean (SD), n (%), or median, where appropriate
| Pramipexole (n=44) | Placebo (n=39) | Total (n=83) | |
|---|---|---|---|
| Sex (n (%)): | |||
| Male | 30 (68) | 30 (77) | 60 (72) |
| Female | 14 (32) | 9 (23) | 23 (28) |
| Age (y): | |||
| Mean (SD) | 62.0 (10.1) | 65.4 (7.1) | 63.6 (8.9) |
| Range | 35–80 | 47–80 | 35–80 |
| Duration of PD (y): | |||
| Mean (SD) | 6.5 (4.0) | 6.0 (3.5) | 6.3 (3.8) |
| Range | 0.9–17 | 2.0–16 | 0.9–17 |
| Duration of drug treatment (y): | |||
| Mean (SD) | 3.9 (3.1) | 3.6 (3.5) | 3.8 (3.3) |
| Levodopa dose (mg): | |||
| Median | 300 | 300 | 300 |
| Range | 50–700 | 100–1700 | 50–1700 |
| Patients (n (%)): | |||
| With no levodopa | 5 (11) | 5 (13) | 10 (12) |
| ≤300 mg | 25 (57) | 18 (46) | 43 (52) |
| >300 mg | 14 (32) | 16 (41) | 30 (36) |
| Patients without “off” periods (at baseline) (n (%)) | 22 (50) | 16 (41) | 38 (46) |
| Hoehn and Yahr Stage: in “on” periods (n (%)): | |||
| I | 6 (14) | 4 (10) | 10 (12) |
| I.5 | 4 (9) | 5 (13) | 9 (11) |
| II | 22 (50) | 20 (51) | 42 (51) |
| II.5 | 10 (23) | 7 (18) | 17 (20) |
| III | 2 (4) | 3 (8) | 5 (6) |
| IV | 0 | 0 | 0 |
| Hoehn and Yahr Stage: in “off” periods (n (%)): | |||
| I | 0 | 1 (3) | 1 (1) |
| I.5 | 0 | 2 (5) | 2 (2) |
| II | 3 (7) | 6 (15) | 9 (11) |
| II.5 | 12 (27) | 10 (26) | 22 (27) |
| III | 7 (16) | 4 (10) | 11 (13) |
| IV | 0 | 1 (3) | 1 (1) |
| Tremor score (mean (SD)) | 11.9 (5) | 10.9 (3.5) | 11.4 (4.3) |
| Item 16 (reported) | 2.2 (0.8) | 2.1 (0.7) | 2.2 (0.7) |
| Item 20 (rest) | 6.3 (3.4) | 5.8 (2.2) | 6.1 (2.9) |
| Item 21 (action/postural) | 3.3 (1.6) | 3.0 (1.8) | 3.2 (1.7) |
| UPDRS (mean (SD)): | |||
| UPDRS II/III sum score | 47.2 (21.1) | 43.6 (14.4) | 45.5 (18.2) |
| UPDRS II(mean “on/off”) | 13 (6.4) | 11.5 (4.6) | 12.3 (5.7) |
| UPDRS III (“on”) | 34.2 (15.3) | 32.1 (11) | 33.2 (13.4) |
| Patient's diary (mean (SD)): | |||
| Daily living | 20.2 (14.9) | 17.3 (10.8) | 18.8 (13.1) |
| Severity | 6.1 (2.9) | 5.7 (2.3) | 5.9 (2.6) |
| Long term EMG: | |||
| Tremor occurrence (%, mean (SD)) | 41.8 (21.5) | 49.5 (21.6) | 45.5 (21.8) |