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Department of Neurology, The Mount Sinai Medical Center, New York, New York (Dr. Simpson) (Dr. Tagliati)
Daniel Freeman Memorial Hospital and UCLA School of Medicine, Los Angeles, CA (Dr. Alexander)
Movement Disorders Center, The Colorado Neurological Institute, Englewood, CO (Dr. O'Brien)
Allergan, Inc., Irvine, CA. (Dr. Aswad) (Dr. Leon) (Dr. Gibson) (Dr. Mordaunt) (Dr. Monaghan)
Address correspondence and reprint requests to Dr Simpson, Department of Neurology, Mount Sinai Hospital, Box 1052, One Gustave Levy place, New York, NY 10029.
Spasticity is a disorder of excess muscle tone associated with CNS disease. We hypothesized that botulinum toxin, a neuromuscular blocking agent, would reduce tone in spastic muscles after stroke. This randomized, double-blind, placebo-controlled, multicenter clinical trial evaluated the safety and efficacy of botulinum toxin type A (BTXA) in the treatment of chronic upper limb spasticity after stroke. Thirty-nine patients received IM injections of a total dose of either 75, 150, or 300 units of BTXA or placebo into the biceps, flexor carpi radialis, and flexor carpi ulnaris muscles. At baseline, patients demonstrated a mean wrist flexor tone of 2.9 and elbow flexor tone of 2.6 on the Ashworth Scale (0 to 4). Treatment with the 300-unit BTXA dose resulted in a statistically and clinically significant mean decrease in wrist flexor tone of 1.2 (p = 0.028), 1.1 (p = 0.044), and 1.2 (p = 0.026) points and elbow flexor tone of 1.2 (p = 0.024), 1.2 (p = 0.028), and 1.1 (p = 0.199) at weeks 2, 4, and 6 postinjection. In the placebo group, tone reduction at the wrist was 0.3, 0.2, and 0.0 and at the elbow was 0.3,0.3, and 0.6 at weeks 2, 4, and 6 postinjection. BTXA groups reported significant improvement on the physician and patient Global Assessment of Response to Treatment at weeks 4 and 6 postinjection. There were no serious adverse effects. In this 3-month study, BTXA safely reduced upper extremity muscle tone in patients with chronic spasticity after stroke.
Supported by a grant from Allergan, Inc, who supplied the botulinum toxin and placebo used in this study.
Presented in part at the 47th Annual Meeting of the American Academy of Neurology, Seattle, WA, May 1995.
Received August 7, 1995. Accepted in final form October 27, 1995.
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