Abstract: In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to\ntreat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the\ndouble-blind phase of this randomized, controlled trial, we compared the efficacy and safety of\n400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups\nreceived 240UonabotulinumtoxinA injected in the forearm. An additional 160UonabotulinumtoxinA\n(400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar\nmuscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors\nwas greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U\ngroup). Functional disabilities improved in both groups. No substantial difference was found in\nsafety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U\nonabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar\nefficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed.\nThis final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a\nwide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new\nsafety concerns were identified. The dosing data in the open-label phase will inform optimal use of\nonabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167).
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