Back to resultsBOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
onabotulinumtoxinA
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
OnabotulinumtoxinA 400 U
OnabotulinumtoxinA 200 U
Placebo
Arm Description
OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Outcomes
Primary Outcome Measures
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
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 Outcome Measures
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
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.
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
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.
Patient Global Impression of Change (GIC) Using a 7-Point Scale
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.
Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02230956
Brief Title
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Official Title
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OnabotulinumtoxinA 400 U
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
Arm Title
OnabotulinumtoxinA 200 U
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
botulinum toxin Type A, BOTOX®
Intervention Description
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal Saline (placebo) injection into the intra-articular space of the study knee.
Primary Outcome Measure Information:
Title
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
Description
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.
Time Frame
Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
Description
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.
Time Frame
Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Title
Patient Global Impression of Change (GIC) Using a 7-Point Scale
Description
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.
Time Frame
Weeks 1, 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
Description
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.
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Pardubice
Country
Czechia
City
Vejle
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29753118
Citation
McAlindon TE, Schmidt U, Bugarin D, Abrams S, Geib T, DeGryse RE, Kim K, Schnitzer TJ. Efficacy and safety of single-dose onabotulinumtoxinA in the treatment of symptoms of osteoarthritis of the knee: results of a placebo-controlled, double-blind study. Osteoarthritis Cartilage. 2018 Oct;26(10):1291-1299. doi: 10.1016/j.joca.2018.05.001. Epub 2018 May 9.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information
Learn more about this trial
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
We'll reach out to this number within 24 hrs