Title
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
Phase
Phase 1Lead Sponsor
Q-Med ABStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Knee OsteoarthritisIntervention/Treatment
rimabotulinumtoxinB ...Study Participants
22The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.
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
