Botulinum toxin type B: A double-blind, placebo-controlled, safety and efficacy study in cervical dystonia

被引:175
作者
Lew, MF
Adornato, BT
Duane, DD
Dykstra, DD
Factor, SA
Massey, JM
Brin, MF
Jankovic, J
Rodnitzky, RL
Singer, C
Swenson, MR
Tarsy, D
Murray, JJ
Koller, M
Wallace, JD
机构
[1] STANFORD UNIV, PALO ALTO, CA 94304 USA
[2] ARIZONA STATE UNIV, TEMPE, AZ USA
[3] UNIV MINNESOTA, MINNEAPOLIS, MN USA
[4] ALBANY MED COLL, NEW YORK, NY USA
[5] DUKE UNIV, DURHAM, NC USA
[6] MT SINAI MED CTR, NEW YORK, NY 10029 USA
[7] BAYLOR COLL MED, HOUSTON, TX 77030 USA
[8] UNIV IOWA, IOWA CITY, IA USA
[9] UNIV MIAMI, CORAL GABLES, FL 33124 USA
[10] UNIV CALIF SAN DIEGO, LA JOLLA, CA 92093 USA
[11] HARVARD UNIV, SCH MED, BOSTON, MA USA
[12] PRA, CHARLOTTESVILLE, VA USA
[13] ATHENA NEUROSCI INC, SAN FRANCISCO, CA USA
关键词
D O I
10.1212/WNL.49.3.701
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
We enrolled and treated 122 patients with idiopathic cervical dystonia in a double-blind, placebo-controlled safety and efficacy study of botulinum toxin type B (BotB). Both A-responsive and A-resistant patients were enrolled. Patients received intramuscular injections of either BotB (2,500 U, 5,000 U, or 10,000 U) or placebo. The primary outcome measure of efficacy was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at 4 weeks following study drug administration. Secondary measures of efficacy were TWSTRS-Severity, -Disability, and -Pain subscale scores, and Analog Pain Assessment, Investigator Global Assessment, Patient Global Assessment, and Sickness Impact Profile scores. Duration of effect was estimated with an intent-to-treat analysis of responders. Safety measures included clinical parameters, laboratory tests, and adverse events. The primary and most of the secondary analyses indicated a statistically significant treatment effect and a dose response. BotB is safe, well tolerated, and efficacious in the treatment of cervical dystonia at the doses tested.
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收藏
页码:701 / 707
页数:7
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