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

Toxins (Basel). 2018 Jun 21;10(7):253. doi: 10.3390/toxins10070253.

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.

Keywords: ONTIME; abobotulinumtoxinA; botulinum toxin type A; early use; post-stroke; upper limb spasticity.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Botulinum Toxins, Type A / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / etiology
  • Neuromuscular Agents / therapeutic use*
  • Pilot Projects
  • Stroke / complications
  • Stroke / drug therapy*
  • Treatment Outcome
  • Upper Extremity

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A
  • abobotulinumtoxinA

Associated data

  • ClinicalTrials.gov/NCT02321436