Table 1.
Phase III program baseline patient demographics and clinical characteristics.
| Characteristics | Mean (SD)a | ||
|---|---|---|---|
| Levodopa <2000 mg/day (n = 340) | Levodopa ≥2000 mg/day (n = 72) | Overall (N = 412) | |
| Age, years | 64.1 (9.1) | 64.0 (8.4) | 64.1 (8.9) |
| Sex, n (%) | |||
| Female | 151 (44) | 18 (25) | 169 (41) |
| Male | 189 (56) | 54 (75) | 243 (59) |
| Race, n (%) | |||
| White | 312 (92) | 69 (96) | 381 (93) |
| Asian | 23 (7) | 3 (4) | 26 (6) |
| Black/African American | 4 (1) | — | 4 (1) |
| American Indian or Alaska Native | 1 (0.3) | — | 1 (0.2) |
| BMI, kg/m2 | 24.7 (4.5)b | 25.5 (5.3)c | 24.8 (4.7)d |
| Weight, kg | 70.2 (15.6)e | 75.9 (18.7) | 71.2 (16.3)f |
| PD duration, years | 12.3 (5.6) | 12.0 (5.1) | 12.3 (5.5) |
| Baseline oral levodopa dosage, mg/d | 1000.3 (499.6) | 1464.8 (693.3) | 1080.7 (565.3) |
| UPDRS part II score | 16.4 (7.1)g | 16.7 (7.5)h | 16.4 (7.2)i |
| UPDRS part III score | 27.5 (13.7)j | 27.5 (14.5)h | 27.5 (13.9)k |
| Normalized “Off” time, hours | 6.7 (2.3)l | 6.7 (2.2) | 6.7 (2.3)m |
| Normalized “On” time without TSD, hours | 7.7 (2.5)l | 8.1 (2.0) | 7.8 (2.4)m |
| Normalized “On” time with TSD, hours | 1.6 (2.0)l | 1.2 (1.8) | 1.5 (2.0)m |
| Previous PD treatment, n (%) | |||
| Oral levodopa | 340 (100) | 71 (99)n | 411 (100)n |
| Dopamine agonists | 207 (61) | 49 (68) | 256 (62) |
| COMT inhibitors | 101 (30) | 30 (42) | 131 (32) |
| MAO-B inhibitors | 68 (20) | 11 (15) | 79 (19) |
| Amantadine | 120 (35) | 17 (24) | 137 (33) |
“On”/“Off” time was normalized to a 16-hour waking day and averaged for the three days prior to each study visit. aData are shown as mean (SD) except where indicated as n (%). bn: 336; cn: 71; dn: 407; en: 338; fn: 410; gn: 315; hn: 64; in: 379; jn: 313; kn: 377; ln: 334; mn: 406; ndata collection issue for one patient. BMI: body mass index; COMT: catechol-O-methyl transferase; MAO-B: monoamine oxidase B; PD: Parkinson's disease; SD: standard deviation; TSD: troublesome dyskinesia; UPDRS: Unified Parkinson's Disease Rating Scale.