Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 10, 2024
Date Accepted: Jan 13, 2025
The effect of early treatment of spasticity after stroke on motor recovery (Baclotox): Protocol of a randomized double-blind comparison between Botulinum Toxin A, Baclofen, and Placebo
ABSTRACT
Background:
Post-stroke hemiplegics often develop spasticity, which increases disability. Antispastic treatments such as Baclofen and Botulinum Toxin are commonly prescribed in post-stroke recovery. However, their impact on motor recovery, especially when administered within the first two months after stroke, remains unclear.
Objective:
This study compares the motor recovery effects of botulinum toxin versus oral baclofen. The hypothesis is that Botulinum Toxin is more supportive of motor recovery than Baclofen and enhances functional recovery.
Methods:
The study is a multicentric, controlled Phase IV, comparative, prospective, randomised, double-blind, double-dummy, superiority trial to compare the toxin and baclofen, and a non-inferiority trial to compare the toxin and the placebo. It focuses on the time course of Fugl-Meyer Motor Assessment (FMA) as the primary outcome. The main inclusion criterion is patients with a single stroke in the past two months. Treatment comprises one intramuscular injection at treatment initiation and oral tablets for four months. Randomised patients are allocated to three arms: botulinum toxin with placebo baclofen, baclofen with placebo botulinum toxin, and placebo baclofen with placebo botulinum toxin. FMA scores are assessed pre-treatment, one month, and three months later. Spasticity, functional abilities, activities of daily living, pain, and quality of life are also evaluated. Adverse effects are monitored. A positive difference of 13 points in the FMA time course between the botulinum toxin and baclofen groups is considered a relevant effect.
Results:
In june 2024, 178 subjects were randomised across 18 centres, with inclusions delayed due to the COVID-19 pandemic. The data manager currently has all the data, and a review of data quality is in progress. No statistical analysis has been conducted so far, and the blind will be lifted after the analysis.
Conclusions:
This study aims to identify the most suitable spasticity treatment, considering the specificities of the stroke and constraints during the recovery phase. It will provide recommendations for the primary treatment of early spasticity post-stroke. Clinical Trial: This study was registered at http://www.clinicaltrials.gov/ on 1 June 2015 under the number NCT02462317 and in the European clinical trials database (EudraCT) under the number 2010-022881-28.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.