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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2017

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

    • 06 Oct 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Dec 2017.
    • 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, approximately 80 subjects were randomized in this trial as of the end of August 2017. Enrollment of subjects in the trial is ongoing and will continue through the interim analysis.
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