UnknownPhase 3

A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

United States346 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in patient reported pain intensity

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT02746068

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Osteoarthritis, Knee trials