Efficacy and safety of onabotulinumtoxinA with standardized occupational therapy for treatment of pediatric upper limb spasticity: Phase III placebo-controlled randomized trial.

ABSTRACT:

Background

This is the first large study of onabotulinumtoxinA as treatment for pediatric upper limb spasticity.

Objective

Evaluate efficacy and safety of a single treatment with onabotulinumtoxinA plus occupational therapy (OT).

Methods

In this registrational phase III, multinational study (NCT01603602), participants were randomized 1:1:1 to onabotulinumtoxinA 3 U/kg/OT, 6 U/kg/OT, or placebo/OT. Primary endpoint was average change from baseline at weeks 4 and 6 in Modified Ashworth Scale-Bohannon (MAS) score. Secondary endpoints included Modified Tardieu Scale (MTS), Clinical Global Impression of Change (CGI) and functional Goal Attainment Scale (GAS).

Results

235 participants were randomized. At weeks 4 and 6, onabotulinumtoxinA groups had greater mean reduc

SUBMITTER: Dimitrova R 

PROVIDER: S-EPMC8673521 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature