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

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Botulinum toxin; Drug: Placebo

• Registration Number: NCT02139319
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin	Botulinum toxin	Single intra-articular injection
Placebo	Placebo	Single intra-articular injection

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Up to 6 weeks