Abstract
The aim of this study in patients with post-stroke lower limb spasticity (PSLLS) was to evaluate the relationship between time of onabotulinumtoxinA treatment relative to stroke and efficacy outcomes. This was a phase 3, international, multicenter, randomized, 12-week, double-blind study, followed by a repeated treatment, open-label extension. Patients were aged 18–85 years with PSLLS (Modified Ashworth Scale [MAS] ≥ 3) of the ankle with the most recent stroke occurring ≥ 3 months before screening. Patients (double-blind phase) were randomized (n = 468) to onabotulinumtoxinA 300–400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and ≤ 100 U, optional lower limb muscles (flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, and rectus femoris]) or placebo. Primary endpoint: MAS change from baseline (average score of weeks 4 and 6). Secondary endpoints: physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12). When stratified by time since stroke (≤ 24 months, n = 153; > 24 months, n = 315, post hoc), patients treated ≤ 24 months post-stroke experienced greater improvements from baseline versus placebo in MAS (− 0.31 vs − 0.17), CGI (0.49 vs 0.12), and passive GAS scores (week 12, 0.37 vs 0.26). A ≥ − 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04). OnabotulinumtoxinA 300–400 U was well tolerated, with no new safety findings.
Highlights
Post-stroke complications are multifaceted and include spasticity of the upper and lower limbs
OnabotulinumtoxinA (BOTOX®; Allergan plc, Dublin, Ireland) is one type of botulinum toxin approved for the treatment of upper limb spasticity in the United States and most regions worldwide
The ITT population consisted of 153 patients who were treated ≤ 24 months since stroke and 315 patients who were treated > 24 months since stroke
Summary
Post-stroke complications are multifaceted and include spasticity of the upper and lower limbs. Complications associated with spasticity, especially among patients with lower limb spasticity, include impairment of mobility and motor function (Martin et al 2014), the development of contractures (O’Dwyer et al 1996), and reduced quality of life (Doan et al 2012; Urban et al 2010). OnabotulinumtoxinA (BOTOX®; Allergan plc, Dublin, Ireland) is one type of botulinum toxin approved for the treatment of upper limb spasticity in the United States and most regions worldwide. On the basis of an international development program, including the REFLEX Study (Wein et al 2018), onabotulinumtoxinA was approved by the US Food and Drug Administration (Allergan plc 2016) for the treatment of lower limb spasticity in adults and is marketed worldwide (including Australia, Canada, Europe, Japan, and New Zealand) (Adis R&D Insight)
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