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
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
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