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

• ClinicalTrials.gov Identifier: NCT01518257
• Recruitment Status: Completed
• First Posted: January 25, 2012
• Results First Posted: August 7, 2014
• Last Update Posted: August 7, 2014
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Biological: botulinum toxin Type A; Drug: Normal Saline	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: January 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: BOTOX®
Placebo Comparator: Placebo; A single 2 mL dose of Normal Saline (placebo) 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.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 [ Time Frame: Baseline, 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.
2. Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8 [ Time Frame: Baseline, 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.
3. Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12 [ Time Frame: Baseline, 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.

Secondary Outcome Measures :

1. Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score [ Time Frame: Baseline, Week 8 ]
   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.
2. Change From Baseline in WOMAC Pain Score [ Time Frame: Baseline, Week 8 ]
   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.
3. Change From Baseline in WOMAC Physical Function Score [ Time Frame: Baseline, Week 8 ]
   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.
4. Patient Global Impression of Change Score [ Time Frame: Week 8 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Denmark

Aalborg, Denmark

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01518257
• Other Study ID Numbers: 191622-102
• First Posted: January 25, 2012
• Results First Posted: August 7, 2014
• Last Update Posted: August 7, 2014
• Last Verified: July 2014

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents