| Characteristic | Botulinum neurotoxin (N = 20) | Tizanidine (N = 21) | Placebo (N = 19) |
| Cause of spasticity | |||
| Stroke, no (%) | 17 (85.0) | 18 (85.7) | 14 (73.7) |
| TBI, no (%) | 3 (15.0) | 3 (14.3) | 5 (26.3) |
| Age, years (p>0.05): mean (SD), median | |||
| Stroke | 57.2 (9.9), 58.2 | 54.5 (16.3), 54.6 | 54.3 (15.8), 57.7 |
| TBI | 28.2 (7.2), 25.2 | 36.0 (17.0), 31.5 | 43.0 (6.7), 45.9 |
| Total | 52.4 (14.5), 52.7 | 51.9 (17.3), 51.8 | 51.3 (14.7), 51.7 |
| Gender (male), no (%) (p>0.05) | |||
| Stroke | 10 (62.5) | 10 (55.6) | 5 (35.7) |
| TBI | 2 (66.7) | 2 (66.7) | 4 (80.0) |
| Total | 12 (63.2) | 12 (57.1) | 9 (47.4) |
| Race—no (%) (p>0.05) | |||
| Stroke | |||
| Caucasian | 11 (64.7) | 12 (66.7) | 10 (71.4) |
| Hispanic | 1 (5.9) | 1 (5.6) | 0 (0.0) |
| Black | 4 (23.5) | 5 (27.8) | 4 (28.6) |
| Unknown | 1 (5.9) | 0 (0.0) | 0 (0.0) |
| TBI | |||
| Caucasian | 1 (33.3) | 2 (66.7) | 3 (60.0) |
| Black | 2 (66.7) | 1 (33.3) | 1 (20.0) |
| Total | |||
| Caucasian | 12 (60.0) | 14 (66.7) | 13 (68.4) |
| Hispanic | 1 (5.0)) | 1 (4.8) | 0 (0.0) |
| Asian | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Black | 6 (30.0) | 6 (28.6) | 5 (26.3) |
| Unknown | 1 (5.0) | 0 (0.0) | 0 (0.0) |
| Wrist flexor MAS score at baseline (p>0.05) | |||
| Stroke | 3.41 (0.51) | 3.44 (0.62) | 3.14 (0.53) |
| TBI | 3.33 (0.58) | 3.33 (0.58) | 3.80 (0.45) |
| Total | 3.40 (0.50) | 3.43 (0.60) | 3.32 (0.58) |
| Finger flexor MAS score at baseline (p>0.05) | |||
| Stroke | 3.24 (0.83) | 3.11 (0.83) | 3.07 (1.07) |
| TBI | 3.00 (1.73) | 3.67 (0.58) | 2.40 (1.14) |
| Total | 3.20 (0.95) | 3.19 (0.81) | 2.89 (1.10) |
| Treatment | Mean (SD) | ||
| Injected dose (Botox/saline), U (p>0.05) | |||
| Day 0 | 392.0 (139.3) | 414.0 (111.5) | 371.6 (134.9) |
| Titrated dose (TZD/placebo), mg/day | |||
| Week 3 | 21.4 (9.4) | 16.7 (11.6) | 22.4 (6.5) |
| Week 6 | 30.0 (12.3)* | 20.0 (12.1)† | 29.8 (12.5) |
| Week 12 | 26.9 (13.8) | 20.3 (14.2) | 30.5 (12.1) |
| Week 18 | 22.1 (15.5) | 14.7 (13.5)‡ | 32.6 (9.5) |
| Disposition | No (%) | ||
| Study completed up to | |||
| Day 0 | 20 (100.0) | 21 (100.0) | 19 (100.0) |
| Week 3 | 20 (100.0) | 21 (100.0) | 18 (94.7) |
| Week 6 | 19 (95.0) | 18 (85.7) | 19 (100.0) |
| Week 12 | 15 (75.0) | 16 (76.2) | 17 (89.5) |
| Week 18 | 14 (70.0) | 15 (71.4) | 15 (78.9) |
| Week 22 | 16 (80.0) | 13 (61.9) | 14 (73.7) |
| Early terminations | 6 (30.0) | 8 (38.1) | 5 (26.3) |
*p = 0.0195 (Wilcoxon; vs tizanidine (TZD)).
†p = 0.0256 (Wilcoxon; vs placebo).
‡p = 0.0019 (Wilcoxon; vs placebo).
MAS, modified Ashworth Scale; TBI, traumatic brain injury.