This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
346
Change in patient reported pain intensity
Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible)
Time frame: Baseline to Week 24
Patient Global Impression of Change (PGI-C)
Time frame: Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores
Time frame: Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time
Time frame: Baseline to Week 24
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Achieve Clinical Research
Birmingham, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Canoga Park, California, United States
Unnamed facility
El Cajon, California, United States
Unnamed facility
La Mesa, California, United States
Unnamed facility
Long Beach, California, United States
...and 51 more locations