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DEgenerative ROtator Cuff Disease and Botulinum TOXin

NCT05327972 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-27

No results posted yet for this study

Summary

The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.

Conditions

  • Degenerative Rotator Cuff Disease

Interventions

DRUG

The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).

Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.

OTHER

PLACEBO

Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Johann MD BEAUDREUIL, PHD · Hôpital Lariboisière Fernand Widal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327972 on ClinicalTrials.gov