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Title: Early abobotulinumtoxina (Dysport®) in post-stroke adult upper limb spasticity: ONTIME pilot study
Authors: Raymond L. Rosales
Jovita Balcaitiene
Hugues Berard
Pascal Maisonobe
Khean Jin Goh
Witsanu Kumthornthip
Mazlina Mazlan
Lydia Abdul Latif
Mary Mildred D.Delos Santos
Chayaporn Chotiyarnwong
Phakamas Tanvijit
Odessa Nuez
Keng He Kong
University of Santo Tomas, Manila
University of Malaya
University of Malaya Medical Centre
Faculty of Medicine, Siriraj Hospital, Mahidol University
Tan Tock Seng Hospital
Metropolitan Medical Centre
Keywords: Environmental Science;Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Jul-2018
Citation: Toxins. Vol.10, No.7 (2018)
Abstract: © 2018 by the authors. Licensee MDPI, Basel, Switzerland. The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2–12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies.
ISSN: 20726651
Appears in Collections:Scopus 2018

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