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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02139319

Enrollment

Registered

2014-05-15

Start date

2014-03-31

Completion date

2014-07-31

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

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

Interventions

DRUGBotulinum toxin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events	Up to 6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026