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ARTICLE | Clinical News

IDMC recommends continuation of Phase III knee OA trial for Axsome's AXS-02

January 12, 2018 6:02 PM UTC

Axsome Therapeutics Inc. (NASDAQ:AXSM) said an IDMC recommended continuing the Phase III COAST-1 trial of AXS-02 (disodium zoledronate tetrahydrate) to treat pain caused by osteoarthritis (OA) of the knee associated with bone marrow lesions following an interim analysis in 77 patients. AXS-02 was generally well tolerated.

The trial, which has an SPA from FDA, is expected to enroll about 346 patients to receive once-weekly oral AXS-02 or placebo for six weeks. The double-blind, international trial's primary endpoint is the change from baseline in patient-reported pain intensity as measured by Numerical Rating Scale (NRS) score at week 24. Secondary endpoints include Patient Global Impression of Change (PGI-C), Clinician Global Impression of Change (CGI-C) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness subscales over time...