Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518257
• Other study ID #: 191622-102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 23, 2012
• Last updated: July 15, 2014
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Painful osteoarthritis in the study knee

• Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study

Exclusion Criteria:

• Chronic pain conditions other than knee osteoarthritis

• Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year

• Surgery to the study knee within 24 weeks

• Treatment with hyaluronic acid in the study knee within 24 weeks

• Treatment with corticosteroids in the study knee within 12 weeks

• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

• Previous treatment with botulinum toxin of any serotype for any reason

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• botulinum toxin Type A
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.

Drug:
• Normal Saline
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.	Baseline, Week 4	No
Primary	Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.	Baseline, Week 8	No
Primary	Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.	Baseline, Week 12	No
Secondary	Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score	The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.	Baseline, Week 8	No
Secondary	Change From Baseline in WOMAC Pain Score	The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.	Baseline, Week 8	No
Secondary	Change From Baseline in WOMAC Physical Function Score	The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.	Baseline, Week 8	No
Secondary	Patient Global Impression of Change Score	The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.	Week 8	No