TY - JOUR
T1 - Botulinum toxin type b
T2 - A double-blind, placebo controlled, safety and efficacy study in cervical dystonia
AU - Lew, Mark F.
AU - Adornato, B. T.
AU - Duane, D. D.
AU - Dykstra, D. D.
AU - Factor, S. A.
AU - Massey, J. M.
AU - Brin, M. F.
AU - Jankovic, J.
AU - Rodnitzky, R. L.
AU - Singer, C.
AU - Swenson, M. R.
AU - Tarsy, D.
AU - Murray, J. J.
AU - Koller, M.
AU - Wallace, J. D.
PY - 1997/9
Y1 - 1997/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0030853667&partnerID=8YFLogxK
U2 - 10.1212/WNL.49.3.701
DO - 10.1212/WNL.49.3.701
M3 - Article
C2 - 9305326
AN - SCOPUS:0030853667
SN - 0028-3878
VL - 49
SP - 701
EP - 707
JO - Neurology
JF - Neurology
IS - 3
ER -