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Completed

NCT Number: NCT02230956

BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.

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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 2

Primary location

Pardubice, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Painful osteoarthritis
  • Able to discontinue anti-inflammatory drugs and analgesics
  • Must be ambulatory without assistive walking devices

Exclusion criteria

  • Chronic pain conditions other than knee osteoarthritis
  • Treatment with corticosteroids in the study knee within 12 weeks
  • Treatment with hyaluronic acid in the study knee within 24 weeks
  • Previous treatment with any botulinum toxin for any reason
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Treatment and study plan

onabotulinumtoxinA

Biological

onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.

Other names: botulinum toxin Type A, BOTOX®

normal saline

Drug

Normal Saline (placebo) injection into the intra-articular space of the study knee.

Primary outcomes

  1. Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale

    Time frame: Baseline, Week 8

    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale

    Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

    The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.

  2. Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale

    Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

    The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.

  3. Patient Global Impression of Change (GIC) Using a 7-Point Scale

    Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24

    The participant 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 indicate worsening and positive scores indicate improvement.

  4. Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale

    Time frame: Baseline, Week 24

    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2014
Registry last updated
May 31, 2017

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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