Table 1.
Demographic baseline data in all participants and per treatment group
| N | All participants | UB-312 | UB-312 | Placebo |
|---|---|---|---|---|
| 300/100/100 μg | 300/300/300 μg | |||
| 20 | 7 | 7 | 6 | |
| Age, years | ||||
| Mean (s.d.) | 64.1 (9.9) | 67.4 (12.3) | 63.4 (9.0) | 61.0 (8.0) |
| Min; Max | 44; 83 | 44; 83 | 50; 75 | 51; 73 |
| Height, cm | ||||
| Mean (s.d.) | 177.8 (7.9) | 177.4 (4.8) | 176.1 (10.3) | 180.1 (8.4) |
| Min; Max | 159.8; 192.2 | 169.4; 182.0 | 159.8; 188.7 | 166.1; 192.2 |
| Weight, kg | ||||
| Mean (s.d.) | 79.7 (10.5) | 81.5 (10.3) | 75.6 (11.1) | 82.3 (10.3) |
| Min; Max | 62.0; 101.6 | 69.3; 101.6 | 62.0; 96.3 | 66.2; 90.9 |
| BMI, kg m−2 | ||||
| Mean (s.d.) | 25.2 (2.9) | 25.9 (2.6) | 24.4 (3.1) | 25.4 (3.1) |
| Min; Max | 19.7; 30.7 | 22.8; 30.7 | 20.8; 29.4 | 19.7; 28.1 |
| Sex, n (%) | ||||
| Female | 4 (20.0) | 1 (14.3) | 2 (28.6) | 1 (16.7) |
| Male | 16 (80.0) | 6 (85.7) | 5 (71.4) | 5 (83.3) |
| Race, n (%) | ||||
| White | 20 (100) | 7 (100) | 7 (100%) | 6 (100) |
| H&Ya, n (%) | ||||
| 0 (Asymptomatic) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 1 (Unilateral involvement only) | 2 (10.0) | 0 (0) | 2 (28.6) | 0 (0) |
| 2 (Bilateral involvement without balance impairment) | 16 (80.0) | 7 (100) | 4 (57.1) | 5 (83.3) |
| 3 (Mild-to-moderate involvement) | 2 (10.0) | 0 (0) | 1 (14.3) | 1 (16.7) |
| MDS–UPDRS part II total scorea | ||||
| Mean (s.d.) | 10.5 (6.23) | 14.1 (6.77) | 8.4 (5.38) | 8.5 (5.32) |
| Min; Max | 1; 27 | 6; 27 | 1; 15 | 1; 16 |
| MDS–UPDRS part III total scorea | ||||
| Mean (s.d.) | 33.5 (15.37) | 37.1 (14.72) | 37.4 (19.92) | 24.7 (5.28) |
| Min; Max | 8; 60 | 23; 62 | 8; 60 | 18; 31 |
| MoCA total scorea | ||||
| Mean (s.d.) | 27.1 (2.17) | 26.9 (2.12) | 27.0 (2.71) | 27.5 (1.87) |
| Min; Max | 21; 30 | 23;29 | 21; 29 | 25; 30 |
| Parkinson duration, years | ||||
| Mean (s.d.) | 6.8 (4.3) | 7.4 (3.8) | 7.6 (5.4) | 5.0 (3.5) |
| Min; Max | 1; 16 | 2;13 | 2; 16 | 1; 11 |
| Anti-Parkinson drugs, n (%) | ||||
| Levodopa | 18 (90.0) | 7 (100) | 5 (71.4) | 6 (100) |
| Dopamine agonists | 10 (50.0) | 5 (71.4) | 3 (42.9) | 2 (33.3) |
| MAO-B inhibitors | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Baseline characteristics were comparable between study groups, including H&Y stage and duration of PD.
aMeasured prevaccination on day 1.