Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study.

ABSTRACT:

Objective

To evaluate safety (primary objective) and efficacy of increasing doses (400 U up to 800 U) of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for patients with limb spasticity.

Methods

In this prospective, single-arm, dose-titration study (NCT01603459), patients (18-80 years) with spasticity due to cerebral causes, who were clinically deemed to require total doses of 800 U incobotulinumtoxinA, received 3 consecutive injection cycles (ICs) with 400 U, 600 U, and 600-800 U incobotulinumtoxinA, respectively, each followed by 12-16 weeks' observation. Outcomes included adverse events (AEs), antibody testing, Resistance to Passive Movement Scale (REPAS; based on the Ashworth Scale), and Goal Attainment Scale.

Results

In total, 155 patients were enrolled.

SUBMITTER: Wissel J 

PROVIDER: S-EPMC5379931 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature