A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
NCT ID: NCT02746068
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
346 participants
INTERVENTIONAL
2016-03-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AXS-02
Administered orally in the morning for 6 weeks
AXS-02
Placebo
Administered orally in the morning for 6 weeks
Placebo
Interventions
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AXS-02
Placebo
Eligibility Criteria
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Inclusion Criteria
* Meets the ACR clinical criteria for knee osteoarthritis
* Bone Marrow Lesion of the knee present on MRI
* Additional criteria may apply
Exclusion Criteria
* Any prior use of bisphosphonates within 6 months of screening
* Additional criteria may apply
50 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Achieve Clinical Research
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Hot Springs, Arkansas, United States
Anaheim, California, United States
Canoga Park, California, United States
El Cajon, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
North Hollywood, California, United States
Sacramento, California, United States
San Diego, California, United States
Thousand Oaks, California, United States
Upland, California, United States
Denver, Colorado, United States
Milford, Connecticut, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Clermont, Florida, United States
Hialeah, Florida, United States
Jupiter, Florida, United States
Lauderdale Lakes, Florida, United States
Orlando, Florida, United States
Accord Clinical Research
Port Orange, Florida, United States
Port Saint Lucie, Florida, United States
Sarasota, Florida, United States
Canton, Georgia, United States
Chicago, Illinois, United States
Affinity Clinical Research Institute
Oak Lawn, Illinois, United States
Oak Lawn, Illinois, United States
Newton, Kansas, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
North Attleboro, Massachusetts, United States
Quincy, Massachusetts, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Hartsdale, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Duncansville, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Franklin, Tennessee, United States
Austin, Texas, United States
Baytown, Texas, United States
DeSoto, Texas, United States
Wichita Falls, Texas, United States
Newport News, Virginia, United States
Bellevue, Washington, United States
Broadmeadow, New South Wales, Australia
Noosa, Queensland, Australia
Adelaide, South Australia, Australia
Hobart, Tasmania, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Countries
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Other Identifiers
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AXS02-K301
Identifier Type: -
Identifier Source: org_study_id
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