title: Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia.
abstract: 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.
authors.affiliation: Department of Neurology, Indiana University Medical Center, Indianapolis 46202-5250, USA.
authors.forename: A
authors.initials: A
authors.lastname: Brashear
authors.forename: M F
authors.initials: MF
authors.lastname: Lew
authors.forename: D D
authors.initials: DD
authors.lastname: Dykstra
authors.forename: C L
authors.initials: CL
authors.lastname: Comella
authors.forename: S A
authors.initials: SA
authors.lastname: Factor
authors.forename: R L
authors.initials: RL
authors.lastname: Rodnitzky
authors.forename: R
authors.initials: R
authors.lastname: Trosch
authors.forename: C
authors.initials: C
authors.lastname: Singer
authors.forename: M F
authors.initials: MF
authors.lastname: Brin
authors.forename: J J
authors.initials: JJ
authors.lastname: Murray
authors.forename: J D
authors.initials: JD
authors.lastname: Wallace
authors.forename: A
authors.initials: A
authors.lastname: Willmer-Hulme
authors.forename: M
authors.initials: M
authors.lastname: Koller
mesh_terms: 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
chemical_list: C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A