| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From Indiana University Medical Center (Dr. Brashear), Indianapolis, IN; University of Southern California (Dr. Lew), Los Angeles; University of Minnesota (Dr. Dykstra), Minneapolis, MN; Rush Presbyterian-St. Luke’s Medical Center (Dr. Comella), Chicago, IL; Albany Medical College (Dr. Factor), Albany, NY; University of Iowa Hospital (Dr. Rodnitzky), Iowa City, IA; Sinai Clinical Neuroscience Center (Dr. Trosch), West Bloomfield, MI; University of Miami (Dr. Singer), Miami, FL; Mount Sinai Medical Center (Dr. Brin), New York, NY; Pharmaceutical Research Associates (J. Murray), Charlottesville, VA; and Athena Neurosciences, Inc. (Drs. Wallace, Willmer–Hulme, and Koller), San Francisco, CA.
Address correspondence and reprint requests to Dr. Allison Brashear, Department of Neurology, Indiana University Medical Center, 550 University Boulevard, Room 6620, Indianapolis, IN 46202-5250.
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.
Key words: Botulinum toxin type B—NeuroBloc—Clinical trials—Cervical dystonia.
This article has been cited by other articles:
|
|
 |
|
  D. M. Simpson, A. Blitzer, A. Brashear, C. Comella, R. Dubinsky, M. Hallett, J. Jankovic, B. Karp, C. L. Ludlow, J. M. Miyasaki, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology Neurology, May 6, 2008; 70(19): 1699 - 1706. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. P. Mehta and T. A. Hadlock Botulinum Toxin and Quality of Life in Patients With Facial Paralysis Arch Facial Plast Surg, March 1, 2008; 10(2): 84 - 87. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. Dashtipour, M. Barahimi, and S. Karkar Cervical Dystonia Journal of Pharmacy Practice, December 1, 2007; 20(6): 449 - 457. [Abstract] [PDF]
|
|
|
|
 |
|
 B. E Crowner Cervical Dystonia: Disease Profile and Clinical Management Physical Therapy, November 1, 2007; 87(11): 1511 - 1526. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 T. D. Sanger, S. N. Kukke, and S. Sherman-Levine Botulinum Toxin Type B Improves the Speed of Reaching in Children With Cerebral Palsy and Arm Dystonia: An Open-Label, Dose-Escalation Pilot Study J Child Neurol, January 1, 2007; 22(1): 116 - 122. [Abstract] [PDF]
|
|
|
|
 |
|
 M. Z. Atassi On the enhancement of anti-neurotoxin antibody production by subcomponents HA1 and HA3b of Clostridium botulinum type B 16S toxin-haemagglutinin Microbiology, July 1, 2006; 152(7): 1891 - 1895. [Full Text] [PDF]
|
|
|
|
|
|
C. L. Comella, J. Jankovic, K. M. Shannon, J. Tsui, M. Swenson, S. Leurgans, W. Fan, and the Dystonia Study Group Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia Neurology, November 8, 2005; 65(9): 1423 - 1429. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J Jankovic Botulinum toxin in clinical practice J. Neurol. Neurosurg. Psychiatry, July 1, 2004; 75(7): 951 - 957. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C Colosimo, M Chianese, M Giovannelli, M F Contarino, and A R Bentivoglio Botulinum toxin type B in blepharospasm and hemifacial spasm J. Neurol. Neurosurg. Psychiatry, May 1, 2003; 74(5): 687 - 687. [Full Text] [PDF]
|
|
|
|
 |
|
 L. S. Baumann and M. L. Halem Systemic Adverse Effects After Botulinum Toxin Type B (Myobloc) Injections for the Treatment of Palmar Hyperhidrosis Arch Dermatol, February 1, 2003; 139(2): 226 - 226. [Full Text] [PDF]
|
|
|
|
|
|
B. A. Racette, G. Lopate, L. Good, S. Sagitto, and J. S. Perlmutter Ptosis as a remote effect of therapeutic botulinum toxin B injection Neurology, November 12, 2002; 59(9): 1445 - 1447. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A Munchau, C D Good, S McGowan, N P Quinn, J D Palmer, and K P Bhatia Prospective study of swallowing function in patients with cervical dystonia undergoing selective peripheral denervation J. Neurol. Neurosurg. Psychiatry, July 1, 2001; 71(1): 67 - 72. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Munchau, J. D. Palmer, D. Dressler, J. D. O'Sullivan, K. L. Tsang, M. Jahanshahi, N. P. Quinn, A. J. Lees, and K. P. Bhatia Prospective study of selective peripheral denervation for botulinum-toxin resistant patients with cervical dystonia Brain, April 1, 2001; 124(4): 769 - 783. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. S. Edgar Clinical Utility of Botulinum Toxin in the Treatment of Cerebral Palsy: Comprehensive Review J Child Neurol, January 1, 2001; 16(1): 37 - 46. [Abstract] [PDF]
|
|
|
|
|
|
M. F. Brin, M. F. Lew, C. H. Adler, C. L. Comella, S. A. Factor, J. Jankovic, C. O'Brien, J. J. Murray, J. D. Wallace, A. Willmer-Hulme, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia Neurology, October 22, 1999; 53(7): 1431 - 1431. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
