NCT02504008

CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

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 Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.

Conditions

• Complex Regional Pain Syndrome
• Reflex Sympathetic Dystrophy

Interventions

Type	Name	Description
DRUG	AXS-02 (oral zoledronate)	Once weekly for 6 weeks
DRUG	Placebo	Once weekly for 6 weeks

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-07-21
• Last updated: 2018-03-23

Locations

44 sites across 4 countries: United States, Australia, Canada, United Kingdom