CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zolendronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

Trial Profile

CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zolendronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2018

At a glance

  • Drugs Zoledronic acid (Primary)
  • Indications Complex regional pain syndromes; Reflex sympathetic dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms CREATE-1
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 21 Mar 2018 Planned primary completion date changed from 1 Dec 2017 to 1 Jan 2019.
    • 21 Mar 2018 Status changed to active, no longer recruiting.
    • 12 Jan 2018 According to an Axsome Therapeutics media release, an independent data monitoring committee (IDMC) has conducted an interim analysis of the CREATE-1 trial included 81 subjects and recommended that the CREATE-1 trial be stopped for futility.
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