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(Stroke. 2001;32:1841.)
© 2001 American Heart Association, Inc.

Original Contributions

Open-Label Dose-Titration Safety and Efficacy Study of Tizanidine Hydrochloride in the Treatment of Spasticity Associated With Chronic Stroke

David A. Gelber, MD; David C. Good, MD; Alexander Dromerick, MD; Stephen Sergay, MB, BCh Melissa Richardson, MD

From the Department of Neurology (D.A.G.), Southern Illinois University, Springfield, Ill; Departments of Neurology (D.C.G.) and Physical Medicine and Rehabilitation (M.R.), Wake Forest University, Winston-Salem, NC; Department of Neurology (A.D.), Washington University, St Louis, Mo; and Tampa Neurologic Associates (S.S.), Tampa, Fla.

Correspondence to David A. Gelber, MD, Springfield Clinic Neuroscience Institute, 455 W Carpenter, PO Box 19248, Springfield, IL 62794-9248. E-mail Dgelber{at}springfieldclinic.com

Background and Purpose—— Spasticity is a frequently observed motor impairment that develops after stroke; it can cause pain and disability in those affected. The objective of the present study was to evaluate the safety and efficacy of tizanidine, a centrally acting ₂-adrenergic agonist, in the treatment of stroke-related spasticity.

Methods—— Forty-seven patients, who were a minimum of 6 months poststroke and had significant spasticity, were studied at 4 centers. Tizanidine was administered in an open-label manner for 16 weeks, beginning at 2 mg/d and slowly titrated to a maximum of 36 mg/d. The Modified Ashworth Scale, muscle strength testing, functional assessments, and Pain and Functional Spasticity Questionnaires were administered at baseline and at 4, 8, 16, and 18 weeks (after 1 week off tizanidine).

Results—— Spasticity was significantly improved between baseline and week 16, with a decrease in total upper extremity Modified Ashworth Scale score of 2.80±0.47 (P<0.0001). No decline in strength was noted. Treatment with tizanidine resulted in a significant improvement in pain intensity (P=0.0375), quality of life (P=0.0001), and physician assessment of disability (P=0.0001). The most frequent side effects were somnolence (62%) and dizziness (32%). No serious adverse events were considered to be drug related. Ten of 47 patients (21%) were able to reach the maximum daily dosage of 36 mg.

Conclusions—— Overall, the data suggest that tizanidine is safe and efficacious in the treatment of stroke-related spasticity, preserving muscle strength while reducing muscle tone and painful spasms in affected patients.

Key Words: spasticity • stroke • tizanidine

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