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Objective: To determine whether botulinum toxin type B (BTX-B) is effective in controlling upper-limb spasticity., Design: A single-site, double-blind, placebo-controlled, randomized trial and open-label study., Setting: Outpatient., Participants: Subjects with an Ashworth Scale score of 2 or more at the elbow, wrist, and fingers., Interventions: Subjects were injected with 10000 U of BTX-B or placebo at the elbow, wrist, and finger flexors. Main outcome measures Measures recorded at weeks 0, 2, 4, 8, 12, and 16, with a 12-week open-label study. Ashworth Scale score, a global assessment of change (GAC), adverse events and mouse neutralization antibody testing., Results: BTX-B did not decrease muscle tone in the elbow, wrist, or finger flexors at 10000 U over the 16-week period. A decrease in Ashworth Scale score for the BTX-B patient group was present at the wrist at week 2 of the double-blind study (P=.003) but was not statistically significant at other visits. In the open-label study, improvement was noted at week 4 for the elbow (P=.039), wrist (P=.002), finger (P=.001), and thumb flexors (P=.002). In the double-blind study, the Physician GAC did not reach significance. Dry mouth was reported by 8 of 9 BTX-B subjects in the double-blind study. Mouse neutralization antibodies were negative., Conclusions: Our study does not show a significant decrease in tone from 10000 U of BTX-B. Dry mouth was common.

Objective: To determine if botulinum toxin type B (MyoBloc) decreases spasticity., Design: Investigator-initiated trial, open-label, single-treatment session., Setting: Single site., Participants: Ten patients with stable upper-limb spasticity and an Ashworth Scale score of 2 or higher at the elbow, wrist, and fingers., Interventions: Total dose of 10,000U of botulinum toxin type B injected into 5 major muscles., Main Outcome Measures: The Ashworth Scale, goniometry, and functional assessments were performed at injection and weeks 4, 8, and 12. The principal investigator (PI) global assessment of change (GAC) and the patient GAC were done at weeks 4, 8, and 12 postinjection. The safety of the procedure was measured by adverse events and vital signs., Results: Improvements in Ashworth Scale scores were observed at weeks 4, 8, and 12 postinjection. At week 4, the mean changes (in Ashworth score) were elbow, -1.0 (P=.016); wrist, -1.7 (P=.004); finger, -1.35 (P=.02); at week 8: elbow, -.83 (P=.016); wrist, -1.00 (P=.016); finger, -.94 (P=.08); and at week 12: elbow, -.61 (P=.07); wrist, -1.00 (P=.016); and finger, -.89 (P=.10). The PI GAC improved at all visits. Nine of the 10 subjects reported dry mouth at week 4, with resolution by week 12. No changes were seen on the functional measures., Conclusions: Botulinum toxin type B may be useful in treatment of spasticity., (Copyright 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation)