Status:
COMPLETED
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epicondylitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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...
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03380559
Start Date
April 19 2019
End Date
August 19 2021
Last Update
September 21 2023
Active Locations (1)
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1
Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré
Garches, Hauts-de-Seine, France, 92380