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 Sep 2017

At a glance

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

    • 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.
    • 09 May 2017 According to an Axsome Therapeutics media release, readouts are expected 3Q 2017.
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