Table 1. Baseline Characteristics of Participants With Parkinson Disease.
Characteristic | No. (%) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Placebo (n = 25) |
PRX002 Dose Level | All Participants (n = 80) |
|||||||
0.3 mg/kg (n = 8) |
1 mg/kg (n = 8) |
3 mg/kg (n = 8) |
10 mg/kg (n = 8) |
30 mg/kg (n = 11) |
60 mg/kg (n = 12) |
Total (n = 55) |
|||
Age, median (range), y | 58.0 (47-77) | 56.0 (43-78) | 64.0 (48-74) | 58.0 (43-73) | 59.5 (51-65) | 53.0 (43-73) | 55.0 (46-73) | 57.0 (43-78) | 58.0 (43-78) |
Sex | |||||||||
Male | 24 (96.0) | 6 (75.0) | 5 (62.5) | 6 (75.0) | 7 (87.5) | 7 (63.6) | 9 (75.0) | 40 (72.7) | 64 (80.0) |
Female | 1 (4.0) | 2 (25.0) | 3 (37.5) | 2 (25.0) | 1 (12.5) | 4 (36.4) | 3 (25.0) | 15 (27.3) | 16 (20.0) |
Race | |||||||||
White | 24 (96.0) | 7 (87.5) | 8 (100) | 8 (100) | 8 (100) | 11 (100) | 12 (100) | 54 (98.2) | 78 (97.5) |
Asian | 1 (4.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.3) |
Black or African American | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 1 (1.8) | 1 (1.3) |
Body weight, median (range), kg | 79.4 (59-117) | 82.3 (65-96) | 70.3 (46-87) | 74.7 (63-100) | 84.8 (65-106) | 73.9 (52-99) | 79.5 (59-106) | 75.3 (46-106) | 78.7 (46-117) |
Time since onset of symptoms, median (range), y | 7.1 (1-24) | 4.2 (2-10) | 5.4 (3-18) | 4.7 (3-13) | 5.0 (2-9) | 3.0 (2-8) | 4.2 (2-17) | 4.2 (2-18) | 4.6 (1-24) |
Time since diagnosis of PD, median (range), y | 3.9 (1-15) | 2.8 (0-8) | 2.5 (0-12) | 2.5 (1-13) | 3.5 (0-9) | 2.2 (1-6) | 3.1 (1-15) | 3.0 (0-15) | 3.2 (0-15) |
Hoehn and Yahr stage | |||||||||
Stage 1 | 3 (12.0) | 0 | 1 (12.5) | 1 (12.5) | 1 (12.5) | 3 (27.3) | 1 (8.3) | 7 (12.7) | 10 (12.5) |
Stage 2 | 18 (72.0) | 6 (75.0) | 3 (37.5) | 6 (75.0) | 6 (75.0) | 7 (63.6) | 11 (91.7) | 39 (70.9) | 57 (71.3) |
Stage 3 | 4 (16.0) | 2 (25.0) | 4 (50.0) | 1 (12.5) | 1 (12.5) | 1 (9.1) | 0 | 9 (16.4) | 13 (16.3) |
Total MDS-UPDRS score, mean (range) | 48.5 (19-98) | 55.8 (41-71) | 43.9 (15-71) | 52.4 (22-87) | 41.5 (11-59) | 40.5 (14-57) | 50.6 (24-75) | 47.3 (11-87) | 47.7 (11-98) |
Previous use of dopaminergic medications | 24 (96.0) | 7 (87.5) | 5 (62.5) | 8 (100) | 5 (62.5) | 9 (81.8) | 10 (83.3) | 44 (80.0) | 68 (85.0) |
Abbreviations: MDS-UPDRS, Movement Disorder Society–Unified Parkinson’s Disease Rating Scale; PD, Parkinson disease.