OnabotulinumtoxinA for Treatment of Chronic Migraine: Pooled Analyses of the 56-Week PREEMPT Clinical Program (ENG)
26.08.2013
Background.—Chronic migraine is a prevalent, disabling, and undertreated neurological disorder. OnabotulinumtoxinA is
the only approved prophylactic therapy in this highly disabled patient population.
Design and Methods.—Two phase III, 24-week, double-blind, parallel-group, placebo-controlled studies, followed by a
32-week, open-label, single-treatment, onabotulinumtoxinA phase, were conducted (January 23, 2006 to August 11, 2008).
Qualified subjects were randomized (1:1) to injections of onabotulinumtoxinA (155-195 U) or placebo every 12 weeks for 5
cycles (double-blind: 2, open-label: 3). The pooled primary variable was mean change from baseline in frequency of headache
days. Secondary variables included proportion of patients with severe Headache Impact Test-6 score (60) and mean changes
from baseline in frequencies of migraine days, moderate/severe headache days, and migraine episodes; cumulative hours
of headache on headache days; and acute headache medication intakes. The primary time point was week 24. Assessments
for the open-label phase (all patients treated with onabotulinumtoxinA) compared double-blind treatment groups
Автор: Sheena K. Aurora, MD; Paul Winner, DO; Marshall C. Freeman, MD; Egilius L. Spierings, MD, PhD; Jessica O. Heiring, MD; Ronald E. DeGryse, MS; Amanda M. VanDenburgh, PhD; Marissa E. Nolan, PhD; Catherine C. Turkel, PharmD, PhD
Год публикации: 2011
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