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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Epicondylitis

Treatments: Drug: Injection, placebo of toxin + corticoid; Drug: Injection, botulinum toxin + placebo corticoid; Drug: Injection, botulinum toxin + corticoid

Study type: Interventional

Funder types: Other

Identifiers

NCT03380559

2017-001709-33 (EudraCT Number)

P160926J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged between 18 and 60 years;
• Physical disability or not;
• Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
• Signed consent obtained;
• Covered by health insurance.

Exclusion criteria

• Central nervous system disorders result in spasticity in epicondylitis limb;
• History of severe psychiatric disorder;
• History of myasthenia gravis;
• Pregnant or breastfeeding woman;
• Unable to understand or respond to questions;
• Contraindication to botulinum toxin or corticoid;
• Treatment with botulinum toxin 3 months prior to baseline;
• Anticoagulant theraphy;
• Difficult to follow-up in the study;
• Patient under guardianship, or deprived of liberty by a judicial order.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups, including a placebo group

Group A : Association (botulinum toxin + corticoid)

Experimental group

Treatment:

Drug: Injection, botulinum toxin + corticoid

Group C : placebo of toxin + corticoid :

Placebo Comparator group

Treatment:

Drug: Injection, placebo of toxin + corticoid

Group T : botulinum toxin + placebo corticoid

Active Comparator group

Treatment:

Drug: Injection, botulinum toxin + placebo corticoid