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

Galderma

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: Placebo; Drug: Botulinum toxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02139319

43QM1309

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

Botulinum toxin

Experimental group

Description:

Single intra-articular injection

Treatment:

Drug: Botulinum toxin

Placebo

Placebo Comparator group

Description:

Single intra-articular injection

Treatment:

Drug: Placebo