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From the University of Southern California (Dr. Lew) Los Angeles, CA; Stanford University (Dr. Adornato), Palo Alto, CA; Arizona State, University (Dr. Duane), Tempe, AZ; University of Minnesota (Dr. Dykstra), Minneapolis MN; Albany Medical College (Dr. Factor), NY; Duke University (Dr. Massey), Durham, NC; Mt. Sinai Medical Center (Dr. Brin), New York, NY; Baylor College of Medicine (Jankovic), Houston, TX; University of Iowa (Rodnitzky), Iowa City, IA; the University of Miami (Dr. Singer), FL; the University of California-San Diego (Dr. Swenson), CA; Harvard Medical School (Dr. Tarsy), Boston, MA; PRA (Mr. Murray), Charlottesville, VA; Athena Neurosciences, Inc.(Drs. Koller and Wallace), San Francisco, CA.
Address correspondence and reprint requests to Dr. Mark F. Lew, University of Southern California, 1510 San Pablo Street, Suite 268, Los Angeles, CA 90033-4606.
We enrolled and treated 122 patients with idiopathic cervical dystonia in a double-blind, placebo-controlled safety and efficacy study of botulinum toxin type B (BotB). Both A-responsive and A-resistant patients were enrolled. Patients received intramuscular injections of either BotB (2,500 U, 5,000 U, or 10,000 U) or placebo. The primary outcome measure of efficacy was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at 4 weeks following study drug administration. Secondary measures of efficacy were TWSTRS-Severity, -Disability, and -Pain subscale scores, and Analog Pain Assessment, Investigator Global Assessment, Patient Global Assessment, and Sickness Impact Profile scores. Duration of effect was estimated with an intent-to-treat analysis of responders. Safety measures included clinical parameters, laboratory tests, and adverse events. The primary and most of the secondary analyses indicated a statistically significant treatment effect and a dose response. BotB is safe, well tolerated, and efficacious in the treatment of cervical dystonia at the doses tested.
Received December 11, 1996. Accepted in final form April 10, 1997.
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