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: 08 Nov 2017

At a glance

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

    • 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.
    • 07 Sep 2017 According to an Axsome Therapeutics media release, interim analysis results for both CREATE-1(for efficacy) and COAST-1 (to assess the assumptions used to determine the sample size of the study) trials anticipated late December 2017 to early January 2018.
    • 07 Sep 2017 According to an Axsome Therapeutics media release, the company announced that the interim efficacy analysis of CREATE-1 trial will be performed by an independent data monitoring committee (IDMC) and is expected year-end 2017. It also mentioned that, because of member availability and for efficiency, the IDMC will analyze both CREATE-1 and COAST-1 trials at the same committee meeting.
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