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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Q-Med AB
• Treatments: Botulinum Toxins

Criteria

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