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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01518257
First received: January 23, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Osteoarthritis
Biological: botulinum toxin Type A
Drug: Normal Saline
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in WOMAC Pain Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in WOMAC Physical Function Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Patient Global Impression of Change Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518257

Locations
Denmark
Aalborg, Denmark
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01518257     History of Changes
Other Study ID Numbers: 191622-102
Study First Received: January 23, 2012
Results First Received: July 15, 2014
Last Updated: July 15, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014