Raymond L. RosalesJovita BalcaitieneHugues BerardPascal MaisonobeKhean Jin GohWitsanu KumthornthipMazlina MazlanLydia Abdul LatifMary Mildred D.Delos SantosChayaporn ChotiyarnwongPhakamas TanvijitOdessa NuezKeng He KongUniversity of Santo Tomas, ManilaUniversity of MalayaUniversity of Malaya Medical CentreFaculty of Medicine, Siriraj Hospital, Mahidol UniversityIpsenTan Tock Seng HospitalMetropolitan Medical Centre2019-08-232019-08-232018-07-01Toxins. Vol.10, No.7 (2018)207266512-s2.0-85049060906https://repository.li.mahidol.ac.th/handle/20.500.14594/45879© 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.Mahidol UniversityEnvironmental SciencePharmacology, Toxicology and PharmaceuticsArticleSCOPUS10.3390/toxins10070253