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Completed

NCT Number: NCT01518257

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

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 names: BOTOX®

normal saline

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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