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From the Mount Sinai School of Medicine (Dr. Brin), New York, NY; University of Southern California (Dr. Lew), Los Angeles, CA; Mayo Clinic Scottsdale (Dr. Adler), Scottsdale, AZ; Rush Presbyterian–St. Luke’s Medical Center (Dr. Comella), Chicago, IL; Albany Medical Center (Dr. Factor), Albany, NY; Baylor College of Medicine (Dr. Jankovic), Houston, TX; Colorado Neurological Institute (Dr. O’Brien), Denver, CO; Pharmaceutical Research Associates, Inc. (J. Murray), Charlottesville, VA; and Athena Neurosciences, Inc. (Drs. Wallace, Willmer–Hulme, and Koller), San Francisco, CA.
Address correspondence and reprint requests to Dr. Mitchell F. Brin, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1052, New York, NY 10029-6574.
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.
Key words: Botulinum toxin type B—NeuroBloc—Clinical trials—Cervical dystonia—Torticollis—BoNT/B.
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