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: 08 Nov 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

    • 08 Nov 2017 According to an Axsome Therapeutics media release, approximately 85 subjects have been randomized to date in this trial.
    • 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.
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