Table 1. Baseline demographics and characteristics (ITT populations).
aboBoNT-A | Placebo | |
---|---|---|
n = 89 | n = 45 | |
Female sex, n (%) | 59 (66.3) | 28 (62.2) |
Age (years; mean ± SD) | 57.3 ± 11.11 | 56.5 ± 11.74 |
Caucasian/white race, n (%) | 84 (94.4) | 42 (93.3) |
Type of CD, n (%) | ||
Torticollis | 75 (84.3) | 39 (86.7) |
Laterocollis | 54 (60.7) | 30 (66.7) |
Anterocollis | 17 (19.1) | 7 (15.6) |
Retrocollis | 20 (22.5) | 8 (17.8) |
Lateral shift | 22 (24.7) | 14 (31.1) |
Sagittal shift | 9 (10.1) | 8 (17.8) |
Previous exposure to botulinum neurotoxin, n (%) | ||
Yes | 57 (64.0) | 29 (64.4) |
No | 32 (36.0) | 16 (35.6) |
Previous botulinum neurotoxin treatments for CD, n (%) | ||
n* | 57/57 (100.00) | 29/29 (100.0) |
onaBoNT-A | 56/57 (98.2) | 28/29 (96.6) |
aboBoNT-A | 2/57 (3.5) | 1/29 (3.4) |
incoBoNT-A | 6/57 (10.5) | 2/29 (6.9) |
rimaBoNT-B | 5/57 (8.8) | 2/29 (6.9) |
Most recent CD treatment with onaBoNT-A** | ||
n | 55 | 25 |
Mean dose*** (U; mean ± SD) | 177.0 ± 34.0 | 176.2 ± 42.2 |
Mean time since last injection (months; mean ± SD) | 4.8 ± 19.1 | 3.6 ± 16.3 |
*Subjects may have been previously treated with ≥1 botulinum neurotoxin.
**In subjects who were non-naïve for onaBoNT-A treatment.
***Mean dose of onaBoNT-A exceeds 200 U eligibility requirement due to protocol deviations, patients were excluded from ITT.
aboBoNT-A = abobotulinumtoxinA; CD = cervical dystonia; incoBoNT-A = incobotulinumtoxinA; ITT = intent-to-treat; onaBoNT-A = onabotulinumtoxinA; rimaBoNt-B = rimabotulinumtoxinB; SD = standard deviation.