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A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis — EPITOX  

Epicondylitis Clinical Trial

Official title:
A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

Clinical Trial Summary

The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months. As secondary objectives, the study aims to - demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities. - evaluate tolerance of treatment by grip strength measurement and adverse event collection.

Clinical Trial Description

This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis. All patients will be randomized in 3 following parallel treatment groups: Group A : botulinum toxin + corticoid Group C : placebo of toxin + corticoid Group T : botulinum toxin + placebo corticoid The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03380559
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 3
Start date April 19, 2019
Completion date August 19, 2021
View Details
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