A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia
Identifieur interne : 000031 ( Pmc/Corpus ); précédent : 000030; suivant : 000032A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia
Auteurs : Virgilio Evidente ; Hubert Fernandez ; Mark Ledoux ; Allison Brashear ; Susanne Grafe ; Angelika Hanschmann ; Cynthia ComellaSource :
- Journal of Neural Transmission [ 0300-9564 ] ; 2013.
Abstract
IncobotulinumtoxinA (Xeomin®, NT 201), a preparation without accessory (complexing) proteins, has shown comparable efficacy and safety to onabotulinumtoxinA in treating cervical dystonia (CD). This study evaluated the efficacy and safety of repeated incobotulinumtoxinA injections in subjects with CD. Following a ≤20-week placebo-controlled, randomized, double-blind, single-dose main period, subjects could enter a ≤68-week prospective, randomized, double-blind, repeated-dose, flexible-interval (minimum 6 weeks) extension period with 240 U or 120 U of incobotulinumtoxinA (≤5 injections). Outcome measures included the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AEs). Of 219 subjects completing the main period, 214 were randomized in the extension period to receive incobotulinumtoxinA 240 U (
Url:
DOI: 10.1007/s00702-013-1048-3
PubMed: 23779062
PubMed Central: 3834167
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