Skip to main content
OpenTrials
Completed

NCT Number: NCT02139319

Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee

The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Osteoarthritis of the knee
  • Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
  • Pain score ≥40 mm of the index knee
  • Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen

Exclusion criteria

  • Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
  • Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
  • Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
  • A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments

Treatment and study plan

Botulinum toxin

Drug

Placebo

Drug

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 15, 2014
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.