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(Stroke. 2000;31:2402.)
© 2000 American Heart Association, Inc.

Original Contributions

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of Three Doses of Botulinum Toxin Type A (Dysport) With Placebo in Upper Limb Spasticity After Stroke

A. M. O. Bakheit, MD, PhD; A. F. Thilmann, MD; A. B. Ward, MD; W. Poewe, MD; J. Wissel, MD; J. Muller, MD; R. Benecke, MD; C. Collin, MD; F. Muller, MD; C. D. Ward, MD C. Neumann, MD

From the Stroke Unit, Mount Gould Hospital, Plymouth, UK (A.M.O.B.); Department of Neurological Rehabilitation, Fachklinik Rhein/Ruhr, Essen-Kettwig, Germany (A.F.T.); North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke on Trent, UK (A.B.W.); Universitatsklinik fur Neurologie, Innsbruck, Austria (W.P., J.W., J.M.); Klinik fur Neurologie, Universitat Rostock, Rostock, Germany (R.B.); Department of Rehabilitation Medicine, Battle Hospital, Reading, UK (C.C); Neurologische Klinik Bad Aibling, Bad Aibling, Germany (F.M.); University of Nottingham Rehabilitation Unit, Derby City Hospital, Derby, UK (C.D.W.); and Abteilung Neurologie/Psychologie, Fachklinik Ichenhausen, Ichenhausen, Germany (C.N.).

Correspondence to Prof A.M.O. Bakheit, Stroke Unit, Mount Gould Hospital, Plymouth Pl4 7QD, UK.

Background and Purpose—We sought to define an effective and safe dose of botulinum toxin type A (Dysport) for the treatment of upper limb muscle spasticity due to stroke.

Methods—This was a prospective, randomized, double-blind, placebo-controlled, dose-ranging study. Patients received either a placebo or 1 of 3 doses of Dysport (500, 1000, 1500 U) into 5 muscles of the affected arm. Efficacy was assessed periodically by the Modified Ashworth Scale and a battery of functional outcome measures.

Results—Eighty-three patients were recruited, and 82 completed the study. The 4 study groups were comparable at baseline with respect to their demographic characteristics and severity of spasticity. All doses of Dysport studied showed a significant reduction from baseline of muscle tone compared with placebo. However, the effect on functional disability was not statistically significant and was best at a dose of 1000 U. There were no statistically significant differences between the groups in the incidence of adverse events.

Conclusions—The present study suggests that treatment with Dysport reduces muscle tone in patients with poststroke upper limb spasticity. Treatment was effective at doses of Dysport of 500, 1000, and 1500 U. The optimal dose for treatment of patients with residual voluntary movements in the upper limb appears to be 1000 U. Dysport is safe in the doses used in this study.

Key Words: botulinum toxins • muscle spasticity • stroke

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