Table 1.
Baseline characteristics and demographicsa
| Characteristic | Study No. 6002- | |||||||
| US-005 | US-006 | US-013 | 0608 | 009 | US-018 | EU-007 | 6002-014 | |
| Age (y), n | 195 | 395 | 225 | 357 | 366 | 584 | 455 | 592 |
| Mean (SD) | 63 (9) | 64 (10) | 63 (10) | 65 (8) | 66 (9) | 63 (9) | 62 (9) | 64 (8) |
| [range] | [38–87] | [36–87] | [36–87] | [37–84] | [33–84] | [35–85] | [34–87] | [41–87] |
| Sex, n (%) | ||||||||
| Male | 117 (60) | 264 (67) | 150 (67) | 150 (42) | 162 (44) | 389 (67) | 278 (61) | 363 (61) |
| BMI (kg/m2), n | 195 | 394 | 225 | 357 | 366 | 582 | 455 | 592 |
| Mean (SD) | 26.7 (5.2) | 26.3 (4.5) | 27.0 (5.2) | 21.9 (3.4) | 22.3 (3.5) | 28.1 (5.4) | 25.3 (4.3) | 27.2 (4.9) |
| [range] | [17.8–57.2] | [15.9–45.4] | [17.2–44.9] | [13.8–32.5] | [14.2–40.0] | [15.7–54.4] | [14.4–45.2] | [16.3–46.5] |
| Total OFF time, (hours/day)b, n | 195 | 395 | 225 | 357 | 366 | 584 | 455 | 592 |
| Mean (SD) | 6.3 (2.6) | 5.9 (2.5) | 6.6 (2.5) | 6.6 (2.7) | 6.3 (2.6) | 6.7 (2.1) | 6.4 (2.2) | 5.4 (2.0) |
| [range] | [0.0–14.5] | [0.8–14.8] | [2.5–17.8] | [2.0–17.0] | [1.9–14.2] | [2.0–16.3] | [2.0–14.0] | [1.0–14.3] |
| Total daily dose of levodopa at study entry (mg), n | 195 | 390 | 224 | 357 | 366 | 584 | 454 | 592 |
| Median | 700 | 700 | 700 | 400 | 400 | 750 | 600 | 750 |
| [range] | [150–4800] | [75–2200] | [150–2100] | [300–1500] | [300–1200] | [25–3000] | [105–2000] | [300–3150] |
| UPDRS Part III scorec in the ON state, n | 182 | 388 | 219 | 357 | 366 | 558 | 444 | 592 |
| Mean (SD) | 17.8 (11.1) | 17.0 (9.4) | 23.4 (11.2) | 20.9 (10.3) | 21.2 (11.1) | 22.1 (11.4) | 27.5 (11.8) | 22.7 (11.5) |
| Time since PD diagnosis, y, n | 195 | 395 | 225 | 357 | 366 | 584 | 454 | –d |
| Mean (SD) | 9.9 (5.0) | 9.5 (5.0) | 9.4 (5.1) | 8.2 (4.3) | 7.7 (4.4) | 8.9 (4.8) | 8.3 (4.4) | |
| Time since initiation of levodopa, y, ne | –d | –d | 255 | –d | –d | 584 | 452 | 591 |
| Mean (SD) | 8.1 (5.1) | 7.5 (4.8) | 7.2 (4.2) | 8.7 (4.4) | ||||
| Time since onset of motor complications, ne | 195 | 395 | 225 | 357 | 366 | 582 | 453 | 587 |
| Mean (SD) | 4.1 (3.5) | 4.5 (3.9) | 3.8 (3.5) | 3.3 (2.8) | 3.3 (3.1) | 3.6 (3.4) | 3.1 (2.8) | 6.0 (4.3) |
| Anti-Parkinson medication used at baseline and throughout studyf | ||||||||
| Concomitant anti-Parkinson medications, n (%) | 195 (100.0) | 395 (100.0) | 225 (100.0) | 357 (100.0) | 366 (100.0) | 584 (100.0) | 455 (100.0) | 592 (100.0) |
| DOPA and DOPA derivatives | 195 (100.0) | 395 (100.0) | 225 (100.0) | 357 (100.0) | 366 (100.0) | 584 (100.0) | 455 (100.0) | 592 (100.0) |
| DAs | 150 (76.9) | 301 (76.2) | 171 (76.0) | 330 (92.4) | 318 (86.9) | 430 (73.6) | 226 (49.7) | 463 (78.2) |
| COMT inhibitors | 80 (41.0) | 172 (43.5) | 101 (44.9) | 53 (14.8) | 183 (50.0) | 278 (47.6) | 0 g | 227 (38.3) |
| MAO-B inhibitors | 33 (16.9) | 63 (15.9) | 26 (11.6) | 186 (52.1) | 184 (50.3) | 76 (13.0) | 38 (8.4) | 220 (37.2) |
| Adamantane derivatives | 55 (28.2) | 110 (27.8) | 70 (31.1) | 127 (35.6) | 134 (36.6) | 151 (25.9) | 134 (29.5) | 194 (32.8) |
| Anticholinergics | 9 (4.6) | 18 (4.6) | 21 (9.3) | 64 (17.9) | 50 (13.7) | 24 (4.1) | 84 (18.5) | 27 (4.6) |
| Otherh | 3 (1.5) | 6 (1.5) | 0 | 89 (24.9) | 122 (33.3) | 27 (4.6) | 10 (2.2) | 10 (1.7) |
aITT population, total for all treatment groups in the study, including placebo; bObserved case; cUPDRS Part III score = sum of UPDRS questions 18 to 31 (motor examination); dNot collected; eCalculated relative to screening visit date; fPatients shown as receiving DA, COMT inhibitor, or MAO-B inhibitor may have also been receiving other categories of PD medications; gEntacapone was an active comparator in this study; therefore, concomitant COMT inhibitors were not allowed, per protocol; hPrimarily includes domperidone, droxidopa, promethazine, and zonisamide for Studies 6002-0608 and 6002-009; BMI, body mass index; COMT, catechol-O-methyltransferase; DA, dopamine agonist; ITT, intent-to-treat; MAO-B, monoamine oxidase B; PD, Parkinson’s disease; SD, standard deviation; UPDRS, Unified Parkinson Disease Rating Scale.