Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia.
OBJECTIVE
To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with cervical dystonia (CD).


BACKGROUND
BoNT/B is a form of chemodenervation therapy for the treatment of patients with CD.


METHODS
The authors performed a 16-week, randomized, multicenter, double-blind, placebo-controlled trial of BoNT/B in patients with CD who continue to respond to botulinum toxin type A. Placebo, or 5,000 U or 10,000 U of BoNT/B was administered in two to four muscles involved clinically in CD. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at week 4 was the primary efficacy measure. Clinical assessments and adverse events were recorded for treatment day 1 and at weeks 2, 4, 8, 12, and 16.


RESULTS
A total of 109 patients were enrolled randomly across all three treatment groups. The mean improvement in the TWSTRS-Total scores in each group at week 4 was 4.3 (placebo), 9.3 (5,000 U), and 11.7 (10,000 U). For the prospectively defined primary contrast (10,000 U versus placebo), highly significant differences were noted for the primary (TWSTRS-Total, baseline to week 4, p = 0.0004) and supportive secondary (Patient Global Assessment, baseline to week 4, p = 0.0001) outcome measures. Improvement in pain, disability, and severity of CD occurred for patients who were treated with BoNT/B when compared with placebo-treated patients. Overall, improvements associated with BoNT/B treatment were greatest for patients who received the 10,000-U dose. The duration of treatment effect for BoNT/B was 12 to 16 weeks for both doses.


CONCLUSIONS
Botulinum toxin type B (NeuroBloc) is safe and efficacious at 5,000 U and 10,000 U for the management of patients with cervical dystonia.
Brashear
A
A
Department of Neurology, Indiana University Medical Center, Indianapolis 46202-5250, USA.
Lew
M F
MF
Dykstra
D D
DD
Comella
C L
CL
Factor
S A
SA
Rodnitzky
R L
RL
Trosch
R
R
Singer
C
C
Brin
M F
MF
Murray
J J
JJ
Wallace
J D
JD
Willmer-Hulme
A
A
Koller
M
M
D000328:Adult; D000368:Aged; D001905:Botulinum Toxins / Q000009:adverse effects / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D012720:Severity of Illness Index; D014103:Torticollis / Q000188:drug therapy* / Q000503:physiopathology
C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A