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

NCT03380559 | Completed Phase 3

• 2 other identifiers: P160926J2017-001709-33
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epicondylitis

Keywords

Epicondylitis; Botulinum toxin; Corticoid

Outcome Measures

Primary Outcomes (2)

• Variation of pain intensity between injection of treatment and 6 months after injection

  Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS).

  At the moment of injection

• Variation of pain intensity between injection of treatment and 6 months after injection

  Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS.

  6 months after injection

Secondary Outcomes (9)

• Spontaneous pain intensity at rest

  Before injection, 3 months after injection and 6 months after injection

• Pain intensity of motion of wrist flexion

  Before injection, 3 months after injection and 6 months after injection

• Pain intensity at proximal insertion palpation on epicondylitis muscle

  Before injection, 3 months after injection and 6 months after injection

• Number of days of sick leave

  6 months after injection

• The percentage of patients returning to professional activity or sportive activity

  6 months after injection

Study Arms (3)

Group A : Association (botulinum toxin + corticoid)

EXPERIMENTAL

Drug: Injection, botulinum toxin + corticoid

Group C : placebo of toxin + corticoid :

PLACEBO COMPARATOR

Drug: Injection, placebo of toxin + corticoid

Group T : botulinum toxin + placebo corticoid

ACTIVE COMPARATOR

Drug: Injection, botulinum toxin + placebo corticoid

Interventions

Injection, botulinum toxin + corticoid DRUG

* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Group A : Association (botulinum toxin + corticoid)

Injection, placebo of toxin + corticoid DRUG

* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Group C : placebo of toxin + corticoid :

Injection, botulinum toxin + placebo corticoid DRUG

* 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 %)

Group T : botulinum toxin + placebo corticoid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, 92380, France

Location

MeSH Terms

Interventions

Injections; Botulinum Toxins; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• François Genêt, MD, PhD

  Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ratio 1:1:1

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 21, 2017
• Study Start: April 19, 2019
• Primary Completion: July 7, 2021
• Study Completion: August 19, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)