Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia

A. Brashear, M. F. Lew, D. D. Dykstra, C. L. Comella, S. A. Factor, R. L. Rodnitzky, R. Trosch, Carlos Singer, M. F. Brin, J. J. Murray, J. D. Wallace, A. Willmer-Hulme, M. Koller

Research output: Contribution to journalArticle

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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. Conclusion: 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.

Original languageEnglish
Pages (from-to)1439-1446
Number of pages8
JournalNeurology
Volume53
Issue number7
StatePublished - Oct 22 1999

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Torticollis
Safety
Placebos
Therapeutics
rimabotulinumtoxinB
Type A Botulinum Toxins
Nerve Block
Outcome Assessment (Health Care)
Pain
Muscles

Keywords

  • Botulinum toxin type B
  • Cervical dystonia
  • Clinical trials
  • NeuroBloc

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Brashear, A., Lew, M. F., Dykstra, D. D., Comella, C. L., Factor, S. A., Rodnitzky, R. L., ... Koller, M. (1999). Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia. Neurology, 53(7), 1439-1446.

Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia. / Brashear, A.; Lew, M. F.; Dykstra, D. D.; Comella, C. L.; Factor, S. A.; Rodnitzky, R. L.; Trosch, R.; Singer, Carlos; Brin, M. F.; Murray, J. J.; Wallace, J. D.; Willmer-Hulme, A.; Koller, M.

In: Neurology, Vol. 53, No. 7, 22.10.1999, p. 1439-1446.

Research output: Contribution to journalArticle

Brashear, A, Lew, MF, Dykstra, DD, Comella, CL, Factor, SA, Rodnitzky, RL, Trosch, R, Singer, C, Brin, MF, Murray, JJ, Wallace, JD, Willmer-Hulme, A & Koller, M 1999, 'Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia', Neurology, vol. 53, no. 7, pp. 1439-1446.
Brashear A, Lew MF, Dykstra DD, Comella CL, Factor SA, Rodnitzky RL et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia. Neurology. 1999 Oct 22;53(7):1439-1446.
Brashear, A. ; Lew, M. F. ; Dykstra, D. D. ; Comella, C. L. ; Factor, S. A. ; Rodnitzky, R. L. ; Trosch, R. ; Singer, Carlos ; Brin, M. F. ; Murray, J. J. ; Wallace, J. D. ; Willmer-Hulme, A. ; Koller, M. / Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- responsive cervical dystonia. In: Neurology. 1999 ; Vol. 53, No. 7. pp. 1439-1446.
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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. Conclusion: 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.",
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AU - Brashear, A.

AU - Lew, M. F.

AU - Dykstra, D. D.

AU - Comella, C. L.

AU - Factor, S. A.

AU - Rodnitzky, R. L.

AU - Trosch, R.

AU - Singer, Carlos

AU - Brin, M. F.

AU - Murray, J. J.

AU - Wallace, J. D.

AU - Willmer-Hulme, A.

AU - Koller, M.

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N2 - 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. Conclusion: 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.

AB - 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. Conclusion: 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.

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