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

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Key Inclusion Criteria:

• Male or female of at least 18 years of age

• Recently confirmed diagnosis of CRPS-1 (Budapest criteria)

• Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])

• Willing and able to provide written informed consent

Key Exclusion Criteria:

• Received chronic opioid therapy within 4 weeks

• Received a sympathetic nerve block within 3 weeks

• Active litigation or a pending workers' compensation decision

• Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study