Characteristic | Pooled data | NOH301 [3] | NOH302 [6] | NOH306 | ||||
---|---|---|---|---|---|---|---|---|
Droxidopa (n = 225) | Placebo (n = 235) | Droxidopa (n = 82) | Placebo (n = 80) | Droxidopa (n = 50) | Placebo (n = 51) | Droxidopa (n = 114) | Placebo (n = 108) | |
Mean (SD) age, y | 65.0 (14.7) | 65.4 (15.6) | 57.4 (16.9) | 55.7 (20.0) | 63.1 (13.8) | 66.6 (11.3) | 72.6 (7.5) | 72.4 (8.0) |
Men, n (%) | 132 (58.7) | 142 (60.4) | 42 (51.2) | 42 (52.5) | 30 (60.0) | 32 (62.7) | 77 (67.5) | 68 (63.0) |
White, n (%) | 220 (97.8) | 221 (94.0) | 82 (100) | 75 (93.8) | 49 (98.0) | 48 (94.1) | 110 (96.5) | 102 (94.4) |
Primary clinical diagnosis, n (%) | ||||||||
PD | 150 (66.7) | 157 (66.8) | 35 (42.7) | 31 (38.8) | 21 (42.0) | 23 (45.1) | 114 (100) | 108 (100) |
MSA | 31 (13.8) | 25 (10.6) | 15 (18.3) | 11 (13.8) | 17 (34.0) | 13 (25.5) | 0 | 0 |
Pure autonomic failure | 34 (15.1) | 38 (16.2) | 26 (31.7) | 28 (35.0) | 8 (16.0) | 10 (19.6) | 0 | 0 |
DBHD | 0 | 1 (0.4) | 0 | 0 | 0 | 1 (2.0) | 0 | 0 |
NDAN | 4 (1.8) | 9 (3.8) | 2 (2.4) | 6 (7.5) | 2 (4.0) | 3 (5.9) | 0 | 0 |
Other | 6 (2.7) | 5 (2.1) | 4 (4.9)a | 4 (5.0)b | 2 (4.0)c | 1 (2.0) c | 0 | 0 |
OHSA Item 1 score | ||||||||
N | 224 | 236 | 81 | 79 | 50 | 51 | 92 | 105 |
Mean (SD) | 6.0 (2.2) | 5.8 (2.4) | 6.5 (2.1) | 6.2 (2.4) | 6.6 (2.0) | 6.3 (2.3) | 5.4 (2.1) | 5.1 (2.3) |