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Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group.

Abstract

This multicenter, stratified, randomized, placebo-controlled, double-blind trial evaluated tizanidine for use in the United States for spasticity secondary to MS. The 15-week trial was divided into baseline (weeks 0 and 1), titration (2 mg to a maximum of 36 mg/d; weeks 2 to 4), and plateau (weeks 5 to 13) phases, followed by dose tapering (week 14) and a final visit (week 15). Primary efficacy parameters were scores on muscle tone (Ashworth Scale) and type and frequency of muscle spasms (patient diaries). All efficacy parameters were evaluated by the physician/assessor, and the physician/prescriber was responsible for all dosage adjustments. The patient, physician/assessor, and physician/prescriber made global evaluations of antispastic efficacy. Tizanidine produced a significantly greater reduction than placebo in spasms and clonus (patient diaries) but no significant differences in Ashworth scores. Patients and physician/prescribers, but not physician/assessors, gave significantly better scores in the overall assessment of efficacy and tolerability. No significant differences in other secondary efficacy parameters were noted. Adverse events were reported for 66 (61%) of the 109 placebo-treated patients and 101 (91%) of the 111 tizanidine-treated patients; 6 (6%) and 14 (13%) discontinued treatment, respectively. Patient and physician perception of improvement demonstrated more consistent differences between groups than did the Ashworth Scale, perhaps because of inexperience with this measure or failure to consider time between drug administration and assessment.

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  • Authors+Show Affiliations

    ,

    St. Agnes Hospital, White Plains, New York.

    , , ,

    Source

    Neurology 44:11 Suppl 9 1994 Nov pg S34-42; discussion S42-3

    MeSH

    Adolescent
    Adult
    Aged
    Clonidine
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Multiple Sclerosis
    Muscle Relaxants, Central
    Muscle Spasticity
    Muscle Tonus
    Myoclonus
    Patient Satisfaction
    Spasm

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    7970009

    Citation

    Smith, C, et al. "Tizanidine Treatment of Spasticity Caused By Multiple Sclerosis: Results of a Double-blind, Placebo-controlled Trial. US Tizanidine Study Group." Neurology, vol. 44, no. 11 Suppl 9, 1994, pp. S34-42; discussion S42-3.
    Smith C, Birnbaum G, Carter JL, et al. Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. Neurology. 1994;44(11 Suppl 9):S34-42; discussion S42-3.
    Smith, C., Birnbaum, G., Carter, J. L., Greenstein, J., & Lublin, F. D. (1994). Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. Neurology, 44(11 Suppl 9), pp. S34-42; discussion S42-3.
    Smith C, et al. Tizanidine Treatment of Spasticity Caused By Multiple Sclerosis: Results of a Double-blind, Placebo-controlled Trial. US Tizanidine Study Group. Neurology. 1994;44(11 Suppl 9):S34-42; discussion S42-3. PubMed PMID: 7970009.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group. AU - Smith,C, AU - Birnbaum,G, AU - Carter,J L, AU - Greenstein,J, AU - Lublin,F D, PY - 1994/11/1/pubmed PY - 1994/11/1/medline PY - 1994/11/1/entrez SP - S34-42; discussion S42-3 JF - Neurology JO - Neurology VL - 44 IS - 11 Suppl 9 N2 - This multicenter, stratified, randomized, placebo-controlled, double-blind trial evaluated tizanidine for use in the United States for spasticity secondary to MS. The 15-week trial was divided into baseline (weeks 0 and 1), titration (2 mg to a maximum of 36 mg/d; weeks 2 to 4), and plateau (weeks 5 to 13) phases, followed by dose tapering (week 14) and a final visit (week 15). Primary efficacy parameters were scores on muscle tone (Ashworth Scale) and type and frequency of muscle spasms (patient diaries). All efficacy parameters were evaluated by the physician/assessor, and the physician/prescriber was responsible for all dosage adjustments. The patient, physician/assessor, and physician/prescriber made global evaluations of antispastic efficacy. Tizanidine produced a significantly greater reduction than placebo in spasms and clonus (patient diaries) but no significant differences in Ashworth scores. Patients and physician/prescribers, but not physician/assessors, gave significantly better scores in the overall assessment of efficacy and tolerability. No significant differences in other secondary efficacy parameters were noted. Adverse events were reported for 66 (61%) of the 109 placebo-treated patients and 101 (91%) of the 111 tizanidine-treated patients; 6 (6%) and 14 (13%) discontinued treatment, respectively. Patient and physician perception of improvement demonstrated more consistent differences between groups than did the Ashworth Scale, perhaps because of inexperience with this measure or failure to consider time between drug administration and assessment. SN - 0028-3878 UR - https://www.unboundmedicine.com/medline/citation/7970009/Tizanidine_treatment_of_spasticity_caused_by_multiple_sclerosis:_results_of_a_double_blind_placebo_controlled_trial__US_Tizanidine_Study_Group_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=7970009.ui DB - PRIME DP - Unbound Medicine ER -