A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
- Registration Number
- NCT02746068
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 346
Inclusion Criteria
- Male at least 50 years of age, or postmenopausal female
- Meets the ACR clinical criteria for knee osteoarthritis
- Bone Marrow Lesion of the knee present on MRI
- Additional criteria may apply
Key
Exclusion Criteria
- Previous surgery on index knee
- Any prior use of bisphosphonates within 6 months of screening
- Additional criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered orally in the morning for 6 weeks AXS-02 AXS-02 Administered orally in the morning for 6 weeks
- Primary Outcome Measures
Name Time Method Change in patient reported pain intensity Baseline to Week 24 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)
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change (PGI-C) Week 12 and Week 24 Change in WOMAC pain and stiffness subscales over time Baseline to Week 24 Clinical Global Impression of Change (CGI-C) scores Week 12 and Week 24
Trial Locations
- Locations (3)
Achieve Clinical Research
🇺🇸Birmingham, Alabama, United States
Accord Clinical Research
🇺🇸Port Orange, Florida, United States
Affinity Clinical Research Institute
🇺🇸Oak Lawn, Illinois, United States