COAST -1: Clinical Knee Osteoarthritis Symptom Treatment 1 Study. A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects With Knee Osteoarthritis Associated With Bone Marrow Lesions.
Phase of Trial: Phase III
Latest Information Update: 09 May 2017
At a glance
- Drugs Zoledronic acid (Primary)
- Indications Osteoarthritis; Pain
- Focus Registrational; Therapeutic Use
- Acronyms COAST-1
- Sponsors Axsome Therapeutics
- 09 May 2017 According to an Axsome Therapeutics media release, readouts are expected 3Q 2017.
- 07 Mar 2017 According to an Axsome Therapeutics media release, an interim analysis will now be performed by an independent data monitoring committee on the first approximately 60 subjects enrolled in the trial to assess the assumptions used to determine the sample size of the study. Screening of subjects in this trial will be paused pending results of the interim analysis, and will resume after readouts, anticipated in 2H 2017.
- 03 May 2016 According to an Axsome Therapeutics media release, the company has received Fast Track designation for AXS-02 for the treatment of the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) from the US FDA in May 2016.