This post hoc analysis used pooled upper limb position abnormality, dressing and hygiene data from six prospective, multicenter, phase 2 or 3 studies of incobotulinumtoxinA (Xeomin®; Merz Therapeutics GmbH, Frankfurt, Germany) in the treatment of upper [12 (link),14 (link),17 (link),18 (link),30 ] or upper and lower [15 (link)] limb muscle spasticity in adults conducted by the study sponsor - Merz Therapeutics GmbH (Table 3 ). Studies were limited to Merz-sponsored studies in order to ensure sufficient data availability to conduct the pooled analyses.
MRZ_60201_03071 was terminated prematurely due to low recruitment. It was not registered and no data have been published previously outside of pooled analyses. Four of the studies were randomized, double-blind, and placebo-controlled [12 (link),14 (link),17 (link),30 ], whereas the remaining two studies evaluated different incobotulinumtoxinA dosing schedules [15 (link)] and dilutions [18 (link)].
The studies were conducted across the world and included a range of patient ethnicities. In the six studies, adult patients aged ≥18 years who had not received BoNT-A injections within at least 4 months of screening received incobotulinumtoxinA injections as appropriate for their condition, most commonly at a total body dose of 400 U. Each injection was followed by at least 12 weeks of observation and assessment. In studies where patients received more than one incobotulinumtoxinA injection, the time between injections was 12–14 weeks for the majority of patients [29 (link)].
All studies were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice and were approved by the ethics committee for each participating site. All patients provided written informed consent prior to study participation.
MRZ_60201_03071 was terminated prematurely due to low recruitment. It was not registered and no data have been published previously outside of pooled analyses. Four of the studies were randomized, double-blind, and placebo-controlled [12 (link),14 (link),17 (link),30 ], whereas the remaining two studies evaluated different incobotulinumtoxinA dosing schedules [15 (link)] and dilutions [18 (link)].
The studies were conducted across the world and included a range of patient ethnicities. In the six studies, adult patients aged ≥18 years who had not received BoNT-A injections within at least 4 months of screening received incobotulinumtoxinA injections as appropriate for their condition, most commonly at a total body dose of 400 U. Each injection was followed by at least 12 weeks of observation and assessment. In studies where patients received more than one incobotulinumtoxinA injection, the time between injections was 12–14 weeks for the majority of patients [29 (link)].
All studies were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice and were approved by the ethics committee for each participating site. All patients provided written informed consent prior to study participation.
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