Open-label dose-titration safety and efficacy study of tizanidine hydrochloride in the treatment of spasticity associated with chronic stroke.

Abstract

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 alpha(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.

• Authors: D A Gelber, D C Good, A Dromerick, S Sergay, M Richardson
• Journal: Stroke (Stroke) Vol. 32 Issue 8 Pg. 1841-6 (Aug 2001) ISSN: 1524-4628 [Electronic] United States
• PMID: 11486114 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Muscle Relaxants, Central
• tizanidine
• Clonidine

Topics

• Clonidine (adverse effects, analogs & derivatives, therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Hand Strength
• Humans
• Male
• Middle Aged
• Muscle Relaxants, Central (adverse effects, therapeutic use)
• Muscle Spasticity (drug therapy, etiology)
• Pain (drug therapy, etiology)
• Quality of Life
• Severity of Illness Index
• Stroke (complications)
• Treatment Outcome