• A Brashear, M F Lew, D D Dykstra, C L Comella, S A Factor, R L Rodnitzky, R Trosch, C Singer, M F Brin, J J Murray, J D Wallace, A Willmer-Hulme, and M Koller.
• Department of Neurology, Indiana University Medical Center, Indianapolis 46202-5250, USA.
• Neurology. 1999 Oct 22; 53 (7): 1439-46.

ObjectiveTo determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with cervical dystonia (CD).BackgroundBoNT/B is a form of chemodenervation therapy for the treatment of patients with CD.MethodsThe 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.ResultsA 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.ConclusionBotulinum toxin type B (NeuroBloc) is safe and efficacious at 5,000 U and 10,000 U for the management of patients with cervical dystonia.

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