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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02139319
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Botulinum toxin; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum toxin Single intra-articular injection	Drug: Botulinum toxin
Placebo Comparator: Placebo Single intra-articular injection	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of adverse events [Up to 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		London		United Kingdom

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Q-Med AB, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02139319
• Other Study ID Numbers: 43QM1309
• First Posted: May 15, 2014
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2014

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Botulinum Toxins

Study Results

No Results Posted as of Aug 25, 2022