Evaluation of pain after intra-articular botulinum toxin injections in carpometacarpal osteoarthritis of the thumb

Centre Hospitalier Universitaire De Nice1 site in 1 country60 target enrollmentOctober 18, 2024

DrugsProduct Name : NT 201 Dosage Form : Powder for Solution for lnjection Strength : Placebo 100 Unit (25) USP ges. Packaging : lnjection Vial Manufacturing site(s) : Merz Pharma GmbH & Co. KGaA, Werk Dessau, Am Pharmapark, D-06861 Dessau/ Roßlau Testing site(s) : Merz Pharma GmbH & Co. KGaA, Werk Dessau, Am Pharmapark, D-06861 Dessau/ Roßlau XEOMIN 50 unités, poudre pour solution injectable NT 201 Botulinum toxin type A (150 kD), free from complexing proteins IncobotulinumtoxinA

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Centre Hospitalier Universitaire De Nice
Enrollment: 60
Locations: 1
Primary Endpoint: Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To show that botulinum toxin injection is superior to placebo injection in improving pain in symptomatic trapezometacarpal osteoarthritis at 3 months

Registry

euclinicaltrials.eu

Start Date

October 18, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Centre Hospitalier Universitaire De Nice

Responsible Party

Principal Investigator

Dr Pierre BLANC Investigateur Principal

Scientific

Centre Hospitalier Universitaire De Nice

Eligibility Criteria

Inclusion Criteria

•Patient >18 years old
•Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode
•Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.
•Visual analog scale (VAS) of pain > 4
•Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices

Exclusion Criteria

•History of surgery of the thumb column
•Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months
•Patient who has received a Botulinum toxin injection at any site within the last 3 months
•Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder
•Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)

Outcomes

Primary Outcomes

Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.