Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia.
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.
Lew
M F
MF
University of Southern California, Los Angeles 90033-4606, USA.
Adornato
B T
BT
Duane
D D
DD
Dykstra
D D
DD
Factor
S A
SA
Massey
J M
JM
Brin
M F
MF
Jankovic
J
J
Rodnitzky
R L
RL
Singer
C
C
Swenson
M R
MR
Tarsy
D
D
Murray
J J
JJ
Koller
M
M
Wallace
J D
JD
D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004421:Dystonia / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009334:Neck Muscles / Q000187:drug effects / Q000503:physiopathology*; D010147:Pain Measurement; D010919:Placebos; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D014103:Torticollis / Q000188:drug therapy*; D016896:Treatment Outcome
D018726:Anti-Dyskinesia Agents; D010919:Placebos; D001905:Botulinum Toxins