Table 1.
Baseline characteristics and disease characteristics in the modified intent-to-treat population.
| Parameter | Both Arms (N = 94) | Arm 1 (N = 46) |
Arm 2 (N = 48) |
P Value |
|---|---|---|---|---|
| Dysport → Botox | Botox → Dysport | Arm 1 vs. Arm 2 | ||
| Age at visit 1 (y) | 53.30 ± 10.76 | 53.24 ± 11.44 | 53.35 ± 10.18 | 0.433 |
| Sex (M:F) | 37 : 57 | 20 : 26 | 17 : 31 | 0.527 |
| Time since onset of cervical dystonia (y) | 10.46 ± 8.62 | 11.36 ± 9.21 | 9.57 ± 8.00 | 0.285 |
| Weight at visit 1 (kg) | 60.15 ± 8.27 | 60.03 ± 7.33 | 60.25 ± 9.14 | 0.181 |
| Height at visit 1 (cm) | 162.32 ± 7.39 | 162.66 ± 7.08 | 162.00 ± 7.73 | 0.596 |
| Patients with previous BoNT-A treatment before entry (%) | 40 (42.6) | 17 (37.0) | 23 (47.9) | 0.304 |
| Time since recent BoNT-A treatment before entry (months) | 19.59 ± 27.96 (Range: 5-150) | 12.62 ± 9.56 (Range: 5-40) | 24.37 ± 35.01 (Range: 5-150) | 0.500 |
| Tsui score | 11.12 ± 4.37 | 11.22 ± 4.45 | 11.02 ± 4.34 | 0.285 |
| TWSTRS | 34.90 ± 13.33 | 35.41 ± 14.83 | 34.39 ± 11.85 | 0.081 |
| TWSTRS severity subscale | 16.73 ± 5.72 | 17.46 ± 6.05 | 16.04 ± 5.35 | 0.180 |
| TWSTRS disability subscale | 11.41 ± 5.37 | 11.59 ± 5.90 | 11.25 ± 4.88 | 0.350 |
| TWSTRS pain subscale | 6.74 ± 4.76 | 6.37 ± 5.05 | 7.10 ± 4.48 | 0.096 |
| Number of patients (%) scoring 1 or 2 or 3 in CGI (CGI-I) | 18 (19.1) | 10 (21.7) | 8 (16.7) | 0.605 |
|
P value |
||||
|---|---|---|---|---|
| Mean baseline score in each treatment | Dysport (N = 94) | Botox (N = 94) | Dysport vs. Botox | |
| Tsui score | 10.51 ± 4.66 | 10.73 ± 4.54 | 0.551 | |
| TWSTRS | 33.01 ± 13.90 | 32.49 ± 12.65 | 0.613 | |
| TWSTRS severity subscore | 16.63 ± 6.21 | 15.88 ± 5.85 | 0.095 | |
| TWSTRS disability subscore | 10.76 ± 5.52 | 10.62 ± 4.93 | 0.750 | |
| TWSTRS pain subscore | 5.61 ± 4.84 | 6.12 ± 4.63 | 0.247 | |
| Number of patients (%) scoring 1 or 2 or 3 in CGI (CGI-I)a | 25 (26.6) | 24 (25.5) | 1.000 | |
BoNT-A, Botulinum toxin type A; TWSTRS, Toronto western spasmodic torticollis rating scale; CGI, clinical global impression; CGI-I, clinical global impression of illness.
a
CGI-I is the proportions of patients with CGI of illness of ‘1 = normal/not at all ill'or ‘2 = borderline mildly ill,' or ‘3 = mildly ill.'