Session Information
Date: Tuesday, June 21, 2016
Session Title: Spasticity
Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: The objective of this analysis is to identify an optimal muscle selection pattern for onabotulinumtoxinA injection for the treatment of post-stroke lower-limb spasticity (PSLLS).
Background: OnabotulinumtoxinA injection has been shown to decrease muscle tone in PSLLS; however, optimal muscle selection patterns for injection have not been previously identified.
Methods: Adults with PSLLS (Modified Ashworth Scale [MAS] ≥3 in the ankle) were enrolled in a multicenter, phase 3, placebo-controlled study. The 12-week double-blind phase randomized patients to onabotulinumtoxinA (300U, mandatory muscles [gastrocnemius, soleus, tibialis posterior] and ≤100U, optional lower limb muscles [flexor digitorum longus (FDL), flexor digitorum brevis, flexor hallucis longus (FHL), extensor hallucis, rectus femoris]) or placebo. The primary endpoint, MAS change from baseline, and a secondary endpoint, physician-assessed Clinical Global Impression of Change (CGI), were each reported as the average score of weeks 4 and 6.
Results: In the intent-to-treat group (n=468), onabotulinumtoxinA significantly improved ankle MAS (–0.81 vs –0.61; P=0.01) and CGI (0.86 vs 0.65; P=0.012) versus placebo. 211 patients received treatment in the mandatory muscles only; 119 received treatment in the mandatory muscles plus FHL and FDL muscles. Injection of the mandatory muscles alone did not improve ankle MAS (P=0.255) or CGI (P=0.576) in all patients; however, it was adequate among those ≤2 years post-stroke (MAS, –1.13 vs –0.62, P=0.019; CGI, 1.24 vs. 0.68, P=0.006). Additional injections into FDL and FHL muscles significantly improved ankle MAS (–0.98 vs –0.52; P=0.002) and CGI (0.80 vs 0.38; P=0.023) versus placebo regardless of their time since stroke. OnabotulinumtoxinA 300-400 U was well tolerated with no new safety findings.
Conclusions: Additional injections of onabotulinumtoxinA into the toe flexors (FDL, FHL) significantly improved ankle MAS and CGI scores compared with injections into the mandatory muscles alone, particularly when treatment was initiated >2 years post-stroke.
1. American Academy of Neurology (AAN) 2016 Annual Meeting, Vancouver, BC, Canada, April 15–21, 2016. 2. World Congress for NeuroRehabilitation (WCNR) 2016, Philadelphia, PA, May 10-13, 2016.
To cite this abstract in AMA style:
T.H. Wein, A. Esquenazi, A.B. Ward, C. Geis, C. Liu, R. Dimitrova. Muscle selection patterns for injection of onabotulinumtoxinA in adult patients with post-stroke lower-limb spasticity influence outcome: Results from a double-blind, placebo-controlled phase 3 clinical trial [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/muscle-selection-patterns-for-injection-of-onabotulinumtoxina-in-adult-patients-with-post-stroke-lower-limb-spasticity-influence-outcome-results-from-a-double-blind-placebo-controlled-phase-3-clinic/. Accessed December 10, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/muscle-selection-patterns-for-injection-of-onabotulinumtoxina-in-adult-patients-with-post-stroke-lower-limb-spasticity-influence-outcome-results-from-a-double-blind-placebo-controlled-phase-3-clinic/