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
- 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.