Publication: Early abobotulinumtoxina (Dysport®) in post-stroke adult upper limb spasticity: ONTIME pilot study
Issued Date
2018-07-01
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ISSN
20726651
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2-s2.0-85049060906
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Mahidol University
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SCOPUS
Bibliographic Citation
Toxins. Vol.10, No.7 (2018)
Suggested Citation
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 Early abobotulinumtoxina (Dysport®) in post-stroke adult upper limb spasticity: ONTIME pilot study. Toxins. Vol.10, No.7 (2018). doi:10.3390/toxins10070253 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/45879
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Title
Early abobotulinumtoxina (Dysport®) in post-stroke adult upper limb spasticity: ONTIME pilot study
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.