Abstract Details

Title OnabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: Results from a double-blind, placebo-controlled, phase 3 clinical trial

Topic Neuro-rehabilitation

Presentation(s) (-)

Poster/Presentation
Number 014

Objective

Background PSLLS management includes antispastics, neuromuscular blocks, physical therapy, orthotics, or surgery, which may be associated with adverse events (AEs) or inadequate response.

Design/Methods Multicenter, phase 3 study with a 12-week double-blind phase where patients with ankle PSLLS (Modified Ashworth Scale [MAS] >=3) were randomized to onabotulinumtoxinA 300U-400U (300U [ankle plantarflexors]; <=100U [other LL muscles]) or placebo. This was followed by an open-label <=3 cycle extension where patients received <=400U (~12 week intervals). The primary endpoint was the average of the weeks 4 and 6 MAS ankle change from baseline. Secondary endpoints included average of weeks 4 and 6 Clinical Global Impression of Change (CGI) physician rating and Goal Attainment Scale (GAS: passive; active) by physician and patient at weeks 8 and 12.

Results 468 patients enrolled, 447 completed the double-blind (95.5%), and 249 completed the study (53.2% [primary database lock]). Demographics were similar between groups. Mean change in MAS was superior for onabotulinumtoxinA (-0.8 vs -0.6 for placebo, P=0.010), including MAS at weeks 2, 4, and 6 (P<=0.027). More onabotulinumtoxinA-treated patients achieved a >=1-grade decrease in MAS (all timepoints; P<=0.044). OnabotulinumtoxinA improved mean CGI (0.9 vs 0.7, P=0.012) and CGI at weeks 2, 4, and 6 (P<=0.035). With onabotulinumtoxinA, GAS by patient improved (passive, –0.6 vs –0.8, P=0.036), as did the proportion that progressed toward active (P=0.009) and passive (P=0.044) goal attainment (by physician). Common AEs with onabotulinumtoxinA group vs placebo included pain in extremity (4.8% vs 4.7%) and nasopharyngitis (3.5% vs 3.0%); common treatment-related AEs included injection site pain (1.7% vs 0.9%) and pain in extremity (0.4% vs 2.1%).

Conclusions OnabotulinumtoxinA (300U-400U) improved MAS, CGI, and some GAS endpoints versus placebo and was well tolerated in patients with PSLLS.

Authors/Disclosures
Theodore Wein, MD (Montreal General Hospital)	No disclosure on file
Alberto Esquenazi, MD (Department of Physical Medicine and Rehabilitation)	Dr. Esquenazi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen and Allergan. Dr. Esquenazi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen and Allergan. The institution of Dr. Esquenazi has received research support from Ipsen, Allergan and Merz.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Rozalina Dimitrova, MD, MPH (Allergan, Inc)	No disclosure on file

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