Clinical Trial Details

Overview

Research Study Summary

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)

Purpose

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.

To Learn more

CW ID: 209806
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Axsome Therapeutics, Inc.
Duration
12 Weeks
Facility Type
Out-Patient

Eligibility

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

More Info

Protocol Number: AXS02-301

Contact

Brittany Harvey
University of South Florida- Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33613
Phone: 813-974-9413

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