Efficacy assessments
| Placebo | 500 Units | 1000 Units | 1500 Units | |
| Maximum distance between knees (cm): | ||||
| Week 0 (mean (SD)) | 28.2 (12.8) | 29.8 (12.1) | 24.9 (11.9) | 28.5 (10.3) |
| Week 4 (mean (SD)) | 32.1 (12.3) | 36.7 (12.8) | 31.9 (9.2) | 39.2 (10.4) |
| (p=0.02) | ||||
| Passive hip abduction (degrees): | ||||
| Week 0 (mean (SD)) | 42.6 (27.5) | 39.4 (20.6) | 39.4 (21.3) | 48.2 (23.0) |
| Week 4 (mean (SD)) | 53.9 (19.7) | 56.5 (24.8) | 63.4 (24.3) | 61.3 (25.4) |
| Active hip abduction: | ||||
| Abduction possible at week 4 (n (%)) | 4 (27) | 5 (26) | 5 (31) | 7 (41) |
| Improved from week 0 (n (%)) | 2 (13) | 1 (5) | 1 (6) | 2 (12) |
| Modified Ashworth score: | ||||
| Week 0 (median) | 12.0 | 8.5 | 16.0 | 14.0 |
| Week 4 (median) | 8.0 | 4.0 | 12.0 | 8.0 |
| Muscle tone: | ||||
| Patients with maximum score at week 0 (n (%)) | 14 (88) | 17 (81) | 18 (90) | 15 (88) |
| Patients with maximum score at week 4 (n (%)) | 13 (87) | 13 (68) | 13 (76) | 10 (59) |
| Spasm frequency: | ||||
| Patients with maximum score at week 0 (n (%)) | 7 (44) | 9 (43) | 13 (65) | 8 (47) |
| Patients with maximum score at week 4 (n (%)) | 3 (20) | 3 (16) | 7 (41) | 4 (24) |
| Clinical global rating: | ||||
| Week 0 (median) | 3.0 | 3.0 | 3.0 | 3.0 |
| Week 4 (median) | 2.0 | 2.0 | 2.0 | 2.0 |
| Upper leg pain: | ||||
| Pain free at week 0 (n (%)) | 3 (19) | 11 (52) | 6 (30) | 7 (41) |
| Pain free at week 4 (n (%)) | 10 (67) | 11 (61) | 7 (41) | 11 (65) |
| Hygiene assessment: | ||||
| Week 0 (median) | 2.0 | 2.0 | 2.0 | 2.0 |
| Week 4 (median) | 2.0 | 2.0 | 1.0 | 1.0 |
| Overall opinions: | ||||
| Investigator: positive3-150response (n (%)) | 7 (44) | 14 (67) | 9 (48) | 6 (36) |
| Patient: positive3-150response (n (%)) | 7 (44) | 13 (62) | 10 (53) | 8 (47) |
| Retreatment with botulinum toxin: | ||||
| Requested or indicated before week 12, (n (%)) | 14 (88) | 13 (62) | 11 (55) | 10 (59) |
| Time to retreatment, days (median) | 56 | 99 | 111 | 119 |
| (n=7) | (n=8) | (n=10) | (n=9) | |
| (p=0.042) | (p=0.017) | (p=0.015) | ||
↵3-150 Positive response defined as excellent, good, or fair.
Statistical comparisons with placebo.