Table 1.
Baseline characteristics.
| Variable | mITT (N = 196) | Baseline OFF ≥ 2.5 h (n = 102) | Baseline OFF < 2.5 h (n = 94) |
|---|---|---|---|
| Age (years), mean ± SD | 64.7 ± 9.2 | 62.9 ± 9.1 | 66.7 ± 8.8 |
| Sex, n (%) male | 109 (55.6) | 54 (52.9) | 55 (58.5) |
| Race, n (%) | |||
| White | 185 (94.4) | 96 (94.1) | 89 (94.7) |
| Other | 11 (5.6) | 6 (5.9) | 5 (5.3) |
| Duration of levodopa treatment (years), mean ± SD | 7.7 ± 4.0 | 8.0 ± 4.0 | 7.3 ± 3.9 |
| Duration of dyskinesia (years), mean ± SD | 3.8 ± 2.8 | 4.1 ± 3.1 | 3.4 ± 2.6 |
| Levodopa dose (mg), mean ± SD | 782 ± 491 | 776 ± 476 | 789 ± 508 |
| LEDD (mg), mean ± SD | 1024 ± 541 | 1026 ± 514 | 1021 ± 573 |
| Concomitant PD medications, n (%) | |||
| Any Dopamine agonist/MAOB/COMT inhibitor1 | 142 (72.4) | 75 (73.5) | 67 (71.3) |
| Dopamine agonist | 106 (54.1) | 60 (58.8) | 46 (48.9) |
| MAOB-inhibitor | 86 (43.9) | 39 (38.2) | 47 (50.0) |
| COMT inhibitor* | 74 (37.8) | 36 (35.3) | 38 (40.4) |
| Anticholinergic | 7 (3.6) | 3 (2.9) | 4 (4.3) |
| OFF time (h) | |||
| Mean ± SD | 2.8 ± 2.1 | 4.4 ± 1.6 | 1.0 ± 0.8 |
| Median [range] | 2.5 [0–9.5] | 4.0 [2.5–9.5] | 1.0 [0–2.3] |
| ON time without troublesome dyskinesia (h); mean ± SD | 8.4 ± 3.1 | 7.3 ± 2.7 | 9.5 ± 3.1 |
| ON time with troublesome dyskinesia (h); mean ± SD | 4.9 ± 2.6 | 4.6 ± 2.2 | 5.2 ± 2.9 |
| MDS-UPDRS | |||
| Total score (Parts 1-3) | 50.5 ± 18.0 | 51.5 ± 19.1 | 49.4 ± 16.7 |
| MDS-UPDRS Part 1 score | 11.4 ± 5.4 | 11.5 ± 5.1 | 11.4 ± 5.7 |
| MDS-UPDRS Part 2 score | 15.2 ± 6.2 | 15.8 ± 6.3 | 14.6 ± 6.2 |
| MDS-UPDRS Part 3 score | 23.8 ± 12.2 | 24.2 ± 14.1 | 23.4 ± 9.9 |
| MDS-UPDRS Part 4 score | 11.1 ± 2.7 | 11.7 ± 2.2 | 10.6 ± 3.1 |
| MDS-UPDRS Part 4 OFF items (4.3 to 4.6) | 6.1 ± 2.5 | 6.8 ± 1.9 | 5.4 ± 2.9 |
| MDS-UPDRS Part 4 Dyskinesia items (4.1 + 4.2) | 5.0 ± 1.1 | 4.9 ± 1.0 | 5.2 ± 1.1 |
| UDysRS Total score | 40.1 ± 12.1 | 41.2 ± 11.8 | 39.0 ± 12.4 |
1Including COMT inhibitor combinations e.g., levodopa, carbidopa, entacapone combination (Stalevo).
LEDD levodopa equivalent daily dose, MAOB monoamine oxidase B, COMT Catechol-O-Methyl-Transferase, MDS-UPDRS Movement Disorder Society - Unified Parkinson’s Disease Rating Scale; The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). UDysRS Unified Dyskinesia Rating Scale.