Table 1.
Parameter | Placebo N = 26 | AboBoNT‐A 1000 U N = 29 | AboBoNT‐A 1500 U N = 28 | All patients N = 83 |
---|---|---|---|---|
Age, years | 51.1 (14.3) [22‐75] | 52.4 (12.1) [26‐73] | 52.4 (12.6) [29‐77] | 52.0 (12.8) [22‐77] |
Male, n (%) | 18 (69.2) | 22 (75.9) | 18 (64.3) | 58 (69.9) |
BMI, kg/m2 | 26.6 (6.0) [16.2‐43.8] | 27.2 (5.5) [20.0‐38.0] | 27.9 (4.3) [20.1‐38.3] | 27.3 (5.2) [16.2‐43.8] |
Affected leg, n (%) | ||||
Left | 15 (57.7) | 22 (75.9) | 12 (42.9) | 49 (59.0) |
Right | 11 (42.3) | 7 (24.1) | 16 (57.1) | 34 (41.0) |
Cause of spasticity, n (%) | ||||
Stroke | 24 (92.3) | 25 (86.2) | 25 (89.3) | 74 (89.2) |
Traumatic brain injury | 2 (7.7) | 4 (13.8) | 3 (10.7) | 9 (10.8) |
Time since event, years | ||||
Stroke | 4.7 (3.1) [1.3‐11.8] | 6.4 (7.1) [0.9‐27.3] | 5.9 (4.8) [0.9‐19.1] | 5.7 (5.2) [0.9‐27.3] |
Traumatic brain injury | 16.0 (7.0) [11.1‐21.0] | 3.8 (2.7) [1.4‐6.5] | 8.4 (3.6) [4.4‐11.3] | 8.1 (6.1) [1.4‐21.0] |
Previous BoNT‐A treatment, n (%) | ||||
OnabotulinumtoxinA | 23 (88.5) | 21 (72.4) | 24 (85.7) | 68 (81.9) |
IncobotulinumtoxinA | 3 (11.5) | 5 (17.2) | 5 (17.9) | 13 (15.7) |
Other | 2 (7.7) | 7 (24.1) | 4 (14.3) | 13 (15.7)* |
Dose of previous BoNT‐A treatment, U | ||||
OnabotulinumtoxinA | 254.2 (120.8) [80‐600] | 251.6 (103.8) [100‐600] | 255.3 (126.8) [50‐600] | 253.8 (117.6) [50‐600] |
IncobotulinumtoxinA | 163.5 (49.7) [100‐200] | 221.7 (98.1) [100‐400] | 284.5 (123.5) [145‐500] | 236.6 (111.1) [100‐500] |
Other | 275.0 (106.1) [200‐350] | 222.5 (121.2) [140‐400] | 1733.3 (3329.7) [200‐8500] | 986.7 (2377.6) [140‐8500] |
BoNT‐A = botulinum toxin A; AboBoNT‐A = abobotulinumtoxinA; BMI = body mass index.*Two patients received Lantox (placebo, n = 1; aboBoNT‐A 1000 U, n = 0; aboBoNT‐A 1500 U, n = 1) and for 11 patients the BoNT‐A type was not specified (placebo, n = 1; aboBoNT‐A 1000 U, n = 7; aboBoNT‐A 1500 U, n = 3). Data are presented for the intention‐to‐treat population and reported as mean (SD) [range] unless otherwise stated.