NCT03380559

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epicondylitis

Interventions

Type	Name	Description
DRUG	Injection, botulinum toxin + corticoid	* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
DRUG	Injection, placebo of toxin + corticoid	* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
DRUG	Injection, botulinum toxin + placebo corticoid	* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)

Timeline

• Start date: 2019-04-19
• Primary completion: 2021-07-07
• Completion: 2021-08-19
• First posted: 2017-12-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: France