Overview
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
Status:
Unknown status
Unknown status
Trial end date:
2020-12-01
2020-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Axsome Therapeutics, Inc.
Criteria
Key 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