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.

Trial Profile

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2018

At a glance

  • Drugs Zoledronic acid (Primary)
  • Indications Pain
  • Focus Registrational; Therapeutic Use
  • Acronyms COAST-1
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 07 Mar 2018 According to an Axsome Therapeutics media release, screening in the trial was paused pending the results of the interim analysis and is anticipated to resume after the final readout from the STRIDE-1 trial
    • 09 Jan 2018 According to an Axsome Therapeutics media release, an independent data monitoring committee (IDMC) has conducted an interim analysis of the COAST-1 trial included 77 patients and recommended to continue the trial.
    • 08 Nov 2017 According to an Axsome Therapeutics media release, an interim analysis will be performed on the first approximately 60 subjects enrolled in the trial. The interim analysis will be performed by the same IDMC and at the same meeting as the interim analysis for the CREATE-1 trial.
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