TY - JOUR
T1 - Tizanidine treatment of spasticity caused by multiple sclerosis
T2 - Results of a double–blind, placebo–controlled trial
AU - US Tizanidine Study Group
AU - Smith, Charles
AU - Birnbaum, Gary
AU - Carter, Jonathan L.
AU - Greenstein, Jeffery
AU - Lublin, Fred D.
AU - Baumel, Barry
AU - Hsu, Chung Y.
AU - Murphy, Frances
AU - Reader, Anthony T.
AU - Schapiro, Randall T.
AU - Sibley, William A.
AU - Stazio, Antonio
AU - Trotter, John L.
AU - Vollmer, Timothy L.
AU - Walshe, Thomas M.
PY - 1994/11
Y1 - 1994/11
N2 - Article 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 11, titration (2 mg to a maximum of 36 mg/d; weeks 2 to 41, 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 physiciadassessor, and the physiciadprescriber was responsible for all dosage adjustments. The patient, physiciadassessor, and physiciadprescriber 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 physiciadprescribers, but not physicadassessors, 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.
AB - Article 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 11, titration (2 mg to a maximum of 36 mg/d; weeks 2 to 41, 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 physiciadassessor, and the physiciadprescriber was responsible for all dosage adjustments. The patient, physiciadassessor, and physiciadprescriber 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 physiciadprescribers, but not physicadassessors, 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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M3 - Article
C2 - 7970009
AN - SCOPUS:19244369207
SN - 0028-3878
VL - 44
SP - S34-S42
JO - Neurology
JF - Neurology
IS - 11
ER -