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

M. F. Brin, M. F. Lew, Charles Howard Adler, C. L. Comella, S. A. Factor, J. Jankovic, C. O'Brien, J. J. Murray, J. D. Wallace, A. Willmer-Hulme, M. Koller

Research output: Contribution to journalArticle

310 Citations (Scopus)

Abstract

Objective: To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with type A-resistant cervical dystonia (CD). Background: Local intramuscular injections of BoNT are an effective therapy for CD. After repeated use, some patients become resistant to therapy. BoNT/B, effective in type A toxin-responsive patients, is proposed as an alternative therapy for type A-resistant patients. Methods: The authors performed a 16-week, double-blind, placebo-controlled trial of BoNT/B in type A-resistant patients with CD. After resistance to therapy was confirmed with the frontalis-type A test, placebo or 10,000 U BoNT/B was administered in a single session into two to four clinically involved muscles. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was the primary efficacy measurement. TWSTRS-Total, three visual analog scales (Patient Global Assessment of Change, Principal Investigator Global Assessment of Change, Patient Analog Pain Assessment), and adverse events were assessed at baseline and weeks 2, 4, 8, 12, and 16. Results: A total of 77 patients participated (38 placebo, 39 active). Improvements in severity, disability, and pain were documented in the BoNT/B-treated group. TWSTRS-Total scores were improved in the BoNT/B-treated group at weeks 4 (p = 0.0001), 8 (p = 0.0002), and 12 (p = 0.0129). All three visual analog scales demonstrated improvements at week 4 (p < 0.0001, 0.0001, and 0.001). A Kaplan-Meier analysis supported a duration of effect of 12 to 16 weeks in the active group. Dry mouth and dysphagia were self-limited adverse effects, reported more commonly in the BoNT/B group. Conclusions: Botulinum toxin type B (BoNT/B) (NeuroBloc) is safe and efficacious for the management of patients with type A-resistant cervical dystonia with an estimated duration of treatment effect of 12 to 16 weeks.

Original languageEnglish (US)
Pages (from-to)1431-1438
Number of pages8
JournalNeurology
Volume53
Issue number7
StatePublished - Oct 22 1999

Fingerprint

Torticollis
Safety
Placebos
Visual Analog Scale
rimabotulinumtoxinB
Intramuscular Injections
Kaplan-Meier Estimate
Pain Measurement
Therapeutics
Complementary Therapies
Deglutition Disorders
Mouth
Research Personnel
Pain
Muscles

Keywords

  • BoNT/B
  • Botulinum toxin type B
  • Cervical dystonia
  • Clinical trials
  • NeuroBloc
  • Torticollis

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Brin, M. F., Lew, M. F., Adler, C. H., Comella, C. L., Factor, S. A., Jankovic, J., ... Koller, M. (1999). Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia. Neurology, 53(7), 1431-1438.

Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia. / Brin, M. F.; Lew, M. F.; Adler, Charles Howard; Comella, C. L.; Factor, S. A.; Jankovic, J.; O'Brien, C.; Murray, J. J.; Wallace, J. D.; Willmer-Hulme, A.; Koller, M.

In: Neurology, Vol. 53, No. 7, 22.10.1999, p. 1431-1438.

Research output: Contribution to journalArticle

Brin, MF, Lew, MF, Adler, CH, Comella, CL, Factor, SA, Jankovic, J, O'Brien, C, Murray, JJ, Wallace, JD, Willmer-Hulme, A & Koller, M 1999, 'Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia', Neurology, vol. 53, no. 7, pp. 1431-1438.
Brin MF, Lew MF, Adler CH, Comella CL, Factor SA, Jankovic J et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia. Neurology. 1999 Oct 22;53(7):1431-1438.
Brin, M. F. ; Lew, M. F. ; Adler, Charles Howard ; Comella, C. L. ; Factor, S. A. ; Jankovic, J. ; O'Brien, C. ; Murray, J. J. ; Wallace, J. D. ; Willmer-Hulme, A. ; Koller, M. / Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia. In: Neurology. 1999 ; Vol. 53, No. 7. pp. 1431-1438.
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abstract = "Objective: To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with type A-resistant cervical dystonia (CD). Background: Local intramuscular injections of BoNT are an effective therapy for CD. After repeated use, some patients become resistant to therapy. BoNT/B, effective in type A toxin-responsive patients, is proposed as an alternative therapy for type A-resistant patients. Methods: The authors performed a 16-week, double-blind, placebo-controlled trial of BoNT/B in type A-resistant patients with CD. After resistance to therapy was confirmed with the frontalis-type A test, placebo or 10,000 U BoNT/B was administered in a single session into two to four clinically involved muscles. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was the primary efficacy measurement. TWSTRS-Total, three visual analog scales (Patient Global Assessment of Change, Principal Investigator Global Assessment of Change, Patient Analog Pain Assessment), and adverse events were assessed at baseline and weeks 2, 4, 8, 12, and 16. Results: A total of 77 patients participated (38 placebo, 39 active). Improvements in severity, disability, and pain were documented in the BoNT/B-treated group. TWSTRS-Total scores were improved in the BoNT/B-treated group at weeks 4 (p = 0.0001), 8 (p = 0.0002), and 12 (p = 0.0129). All three visual analog scales demonstrated improvements at week 4 (p < 0.0001, 0.0001, and 0.001). A Kaplan-Meier analysis supported a duration of effect of 12 to 16 weeks in the active group. Dry mouth and dysphagia were self-limited adverse effects, reported more commonly in the BoNT/B group. Conclusions: Botulinum toxin type B (BoNT/B) (NeuroBloc) is safe and efficacious for the management of patients with type A-resistant cervical dystonia with an estimated duration of treatment effect of 12 to 16 weeks.",
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T1 - Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A- resistant cervical dystonia

AU - Brin, M. F.

AU - Lew, M. F.

AU - Adler, Charles Howard

AU - Comella, C. L.

AU - Factor, S. A.

AU - Jankovic, J.

AU - O'Brien, C.

AU - Murray, J. J.

AU - Wallace, J. D.

AU - Willmer-Hulme, A.

AU - Koller, M.

PY - 1999/10/22

Y1 - 1999/10/22

N2 - Objective: To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with type A-resistant cervical dystonia (CD). Background: Local intramuscular injections of BoNT are an effective therapy for CD. After repeated use, some patients become resistant to therapy. BoNT/B, effective in type A toxin-responsive patients, is proposed as an alternative therapy for type A-resistant patients. Methods: The authors performed a 16-week, double-blind, placebo-controlled trial of BoNT/B in type A-resistant patients with CD. After resistance to therapy was confirmed with the frontalis-type A test, placebo or 10,000 U BoNT/B was administered in a single session into two to four clinically involved muscles. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was the primary efficacy measurement. TWSTRS-Total, three visual analog scales (Patient Global Assessment of Change, Principal Investigator Global Assessment of Change, Patient Analog Pain Assessment), and adverse events were assessed at baseline and weeks 2, 4, 8, 12, and 16. Results: A total of 77 patients participated (38 placebo, 39 active). Improvements in severity, disability, and pain were documented in the BoNT/B-treated group. TWSTRS-Total scores were improved in the BoNT/B-treated group at weeks 4 (p = 0.0001), 8 (p = 0.0002), and 12 (p = 0.0129). All three visual analog scales demonstrated improvements at week 4 (p < 0.0001, 0.0001, and 0.001). A Kaplan-Meier analysis supported a duration of effect of 12 to 16 weeks in the active group. Dry mouth and dysphagia were self-limited adverse effects, reported more commonly in the BoNT/B group. Conclusions: Botulinum toxin type B (BoNT/B) (NeuroBloc) is safe and efficacious for the management of patients with type A-resistant cervical dystonia with an estimated duration of treatment effect of 12 to 16 weeks.

AB - Objective: To determine the safety and efficacy of botulinum toxin type B (BoNT/B) in patients with type A-resistant cervical dystonia (CD). Background: Local intramuscular injections of BoNT are an effective therapy for CD. After repeated use, some patients become resistant to therapy. BoNT/B, effective in type A toxin-responsive patients, is proposed as an alternative therapy for type A-resistant patients. Methods: The authors performed a 16-week, double-blind, placebo-controlled trial of BoNT/B in type A-resistant patients with CD. After resistance to therapy was confirmed with the frontalis-type A test, placebo or 10,000 U BoNT/B was administered in a single session into two to four clinically involved muscles. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was the primary efficacy measurement. TWSTRS-Total, three visual analog scales (Patient Global Assessment of Change, Principal Investigator Global Assessment of Change, Patient Analog Pain Assessment), and adverse events were assessed at baseline and weeks 2, 4, 8, 12, and 16. Results: A total of 77 patients participated (38 placebo, 39 active). Improvements in severity, disability, and pain were documented in the BoNT/B-treated group. TWSTRS-Total scores were improved in the BoNT/B-treated group at weeks 4 (p = 0.0001), 8 (p = 0.0002), and 12 (p = 0.0129). All three visual analog scales demonstrated improvements at week 4 (p < 0.0001, 0.0001, and 0.001). A Kaplan-Meier analysis supported a duration of effect of 12 to 16 weeks in the active group. Dry mouth and dysphagia were self-limited adverse effects, reported more commonly in the BoNT/B group. Conclusions: Botulinum toxin type B (BoNT/B) (NeuroBloc) is safe and efficacious for the management of patients with type A-resistant cervical dystonia with an estimated duration of treatment effect of 12 to 16 weeks.

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KW - Botulinum toxin type B

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KW - Clinical trials

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