Abstract
In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to treat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the double-blind phase of this randomized, controlled trial, we compared the efficacy and safety of 400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups received 240 U onabotulinumtoxinA injected in the forearm. An additional 160 U onabotulinumtoxinA (400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group). Functional disabilities improved in both groups. No substantial difference was found in safety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U onabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar efficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed. This final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a wide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new safety concerns were identified. The dosing data in the open-label phase will inform optimal use of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167).
Highlights
Spasticity has been historically defined as a motor disorder characterized by a velocity-dependentSpasticity has been defined as a practice, motor disorder by a increase in tonic stretch reflexeshistorically[1]
The proportion of male patients was slightly lower in the 400 U group, otherwise no substantial differences were noted between treatment groups
The most frequently reported adverse events (AEs) were nasopharyngitis (11% (7/61) and 17% (11/63) in the 400 U and 240 U groups, respectively) and fall
Summary
Spasticity has been defined as a practice, motor disorder by a increase in tonic stretch reflexeshistorically (muscle tone). In clinical the term ischaracterized often used to describe velocity-dependent increase in tonic stretch reflexes [1]. The term is a wide range of disabling symptoms resulting from muscle overactivity, including continuous muscle often used to describe a wide range disabling symptoms which resulting muscleimpact overactivity, stiffness, involuntary contractions, andofpain and discomfort, canfrom negatively patient including continuous muscle stiffness, involuntary contractions, and pain and discomfort, which can quality of life [2]. Included as part of standard treatment modalities for patients. A included as part limb of standard modalities for with spasticity [3]. Its efficacy and safety for post-stroke upperare limb spasticity have been inpatients randomized controlled[3]
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