Table 1.
Double‐blind | Open‐label | |||
---|---|---|---|---|
First injection | Second injection | Third injection | Fourth injection | |
Walking Velocity (m/s) | n = 220 | n = 316 | n = 253 | n = 150 |
Baseline, * Mean (SD) | 0.452 (0.22) | 0.448 (0.22) | 0.441 (0.22) | 0.433 (0.20) |
Mean (SD) at W12 | 0.521 (0.25) | 0.528 (0.26) | 0.529 (0.27) | 0.521 (0.27) |
Mean change (SD) at W12 | 0.069 (0.11) | 0.081 (0.13) | 0.088 (0.14) | 0.088 (0.14) |
P value (change from baseline) | <.0001 | <.0001 | <.0001 | <.0001 |
Percentage change from baseline at W12 (95% CI) | 19.68 (14.63, 24.73) | 21.59 (17.41, 25.78) | 25.08 (19.80, 30.35) | 23.58 (17.41, 29.76) |
Step Length (m/step) | n = 220 | n = 316 | n = 253 | n = 150 |
Baseline, * Mean (SD) | 0.345 (0.13) | 0.350 (0.13) | 0.346 (0.14) | 0.347 (0.13) |
Mean (SD) at W12 | 0.370 (0.14) | 0.383 (0.14) | 0.387 (0.15) | 0.387 (0.16) |
Mean change (SD) at W12 | 0.025 (0.06) | 0.033 (0.07) | 0.041 (0.07) | 0.040 (0.08) |
P value (change from baseline) | <.0001 | <.0001 | <.0001 | <.0001 |
Percentage change from baseline at W12 (95% CI) | 9.41 (6.64, 12.86) | 11.77 (9.37, 14.17) | 14.48 (11.44, 17.51) | 13.80 (9.45, 18.15) |
Cadence (steps/min) | n = 220 | n = 316 | n = 253 | n = 150 |
Baseline, * Mean (SD) | 76.7 (19.8) | 75.2 (20.4) | 74.9 (20.5) | 73.7 (20.2) |
Mean (SD) at W12 | 82.5 (20.8) | 80.3 (21.8) | 79.8 (21.6) | 78.7 (22.1) |
Mean change (SD) at W12 | 5.8 (11.8) | 5.1 (12.7) | 4.9 (13.3) | 5.0 (12.3) |
P value (change from baseline) | <.0001 | <.0001 | <.0001 | <.0001 |
Percentage change from baseline at W12 (95% CI) | 9.71 (6.21, 13.21) | 8.39 (6.02, 10.76) | 8.66 (5.89, 11.43) | 8.43 (5.23, 11.62) |
Baseline refers to baseline of the double‐blind study, prior to first injection of the patients entering the cycle. aboBoNT‐A, abobotulinumtoxinA; CI, confidence interval; SD, standard deviation; W12, Week 12.