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Toxins 2018, 10(7), 253; https://doi.org/10.3390/toxins10070253

Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study

1
Centre for Neurodiagnostic and Therapeutic Services (CNS), Metropolitan Medical Centre, Manila 1012, Philippines
2
Department of Neurology & Psychiatry, Faculty of Medicine and Surgery, University of Santo Tomas, Manila 1008, Philippines
3
Ipsen Group, Boulogne-Billancourt, 92100 Paris, France
4
Division of Neurology, Department of Medicine, University of Malaya Medical Centre, Kuala Lumpur 59100, Malaysia
5
Department of Rehabilitation Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
6
Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur 50603, Malaysia
7
Department of Rehabilitation Medicine, Tan Tock Seng Hospital, Novena 308433, Singapore
*
Author to whom correspondence should be addressed.
Received: 29 May 2018 / Revised: 11 June 2018 / Accepted: 11 June 2018 / Published: 21 June 2018
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Abstract

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. View Full-Text
Keywords: abobotulinumtoxinA; botulinum toxin type A; upper limb spasticity; post-stroke; early use; ONTIME abobotulinumtoxinA; botulinum toxin type A; upper limb spasticity; post-stroke; early use; ONTIME
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Rosales, R.L.; Balcaitiene, J.; Berard, H.; Maisonobe, P.; Goh, K.J.; Kumthornthip, W.; Mazlan, M.; Latif, L.A.; Delos Santos, M.M.D.; Chotiyarnwong, C.; Tanvijit, P.; Nuez, O.; Kong, K.H. Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study. Toxins 2018, 10, 253.

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