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

Last updated: March 21, 2018
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Trial Status Unknown

Phase

3

Condition

Reflex Sympathetic Dystrophy Syndrome (Rsds)

Chronic Pain

Neuropathy

Treatment

N/A

Clinical Study ID

NCT02504008
AXS02-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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 wouldin the investigator's judgment interfere with the subject's ability to participate inthe study

Study Design

Total Participants: 190
Study Start date:
July 01, 2015
Estimated Completion Date:
January 31, 2019

Connect with a study center

  • Broadmeadow, New South Wales
    Australia

    Site Not Available

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    Camperdown, New South Wales
    Australia

    Site Not Available

  • Hurstville, New South Wales
    Australia

    Site Not Available

  • Noosa Heads, Queensland
    Australia

    Site Not Available

  • Welland, South Australia
    Australia

    Site Not Available

  • empty

    Hobart, Tasmania 7000
    Australia

    Site Not Available

  • Clayton, Victoria
    Australia

    Site Not Available

  • Nedlands, Western Australia
    Australia

    Site Not Available

  • Sherbrooke, Quebec
    Canada

    Site Not Available

  • Warrington, Cheshire
    United Kingdom

    Site Not Available

  • Darlington, County Durham
    United Kingdom

    Site Not Available

  • Lambeth, London
    United Kingdom

    Site Not Available

  • Liverpool, Merseyside
    United Kingdom

    Site Not Available

  • Norwich, Norfolk
    United Kingdom

    Site Not Available

  • Newcastle upon Tyne, Tyne And Wear
    United Kingdom

    Site Not Available

  • Glasgow,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Hot Springs, Arkansas
    United States

    Site Not Available

  • Encinitas, California
    United States

    Site Not Available

  • La Jolla, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • American Spine and Pain MedGroup

    Murrieta, California
    United States

    Site Not Available

  • Napa, California
    United States

    Site Not Available

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    Santa Monica, California 90404
    United States

    Site Not Available

  • Temecula, California
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Clermont, Florida
    United States

    Site Not Available

  • empty

    Jacksonville, Florida 32257
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • empty

    Naples, Florida 34102
    United States

    Site Not Available

  • Orlando, Florida 32827
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • West Palm Beach, Florida
    United States

    Site Not Available

  • Canton, Georgia
    United States

    Site Not Available

  • Marietta, Georgia
    United States

    Site Not Available

  • Saint Marys, Georgia 31558
    United States

    Site Not Available

  • Meridian, Idaho
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

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    Somerset, New Jersey 08873
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Winston-Salem, North Carolina
    United States

    Site Not Available

  • empty

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Bellevue, Washington
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Madison, Wisconsin
    United States

    Site Not Available

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