Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial.
OBJECTIVE
To determine whether botulinum toxin type B (BTX-B) is effective in controlling upper-limb spasticity.


METHODS
A single-site, double-blind, placebo-controlled, randomized trial and open-label study.


METHODS
Outpatient.


METHODS
Subjects with an Ashworth Scale score of 2 or more at the elbow, wrist, and fingers.


METHODS
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.
Brashear
Allison
A
Department of Neurology, Indiana University School of Medicine, Indianapolis, IN 46202, USA. abrashea@iupui.edu
McAfee
Anita L
AL
Kuhn
Elizabeth R
ER
Fyffe
Joanne
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*; D014987:Xerostomia / Q000139:chemically induced
D018726:Anti-Dyskinesia Agents; C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A