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

March 21, 2018 updated by: Axsome Therapeutics, Inc.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia
      • Hurstville, New South Wales, Australia
    • Queensland
      • Noosa Heads, Queensland, Australia
    • South Australia
      • Welland, South Australia, Australia
    • Victoria
      • Clayton, Victoria, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada
  • United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
    • Cheshire
      • Warrington, Cheshire, United Kingdom
    • County Durham
      • Darlington, County Durham, United Kingdom
    • London
      • Lambeth, London, United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom
    • Tyne And Wear
      • Newcastle upon Tyne, Tyne And Wear, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • Encinitas, California, United States
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Napa, California, United States
      • Temecula, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Clermont, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States, 32827
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Canton, Georgia, United States
      • Marietta, Georgia, United States
      • Saint Marys, Georgia, United States, 31558
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Texas
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Washington
      • Bellevue, Washington, United States
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-02 (oral zoledronate)
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Drug: AXS-02 (oral zoledronate)
Once weekly for 6 weeks
Placebo Comparator: Placebo
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Drug: Placebo
Once weekly for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported pain intensity
Time Frame: Baseline to Week 12
Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible).
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory (BPI) Pain Score
Time Frame: Baseline to Week 12
The BPI is a nine-question survey completed by the patient that assesses quality of life and health status. BPI scores range from 0 to 10, with higher values indicating greater pain.
Baseline to Week 12
Patients' Global Impression of Change (PGI-C)
Time Frame: Baseline to Week 12
The PGI-C is a patient/patient's caregiver rated scale to assess the patients overall treatment response. PGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Baseline to Week 12
Clinicians' Global Impression of Change (CGI-C)
Time Frame: Baseline to Week 12
The CGI-C is an investigator-rated scale to assess the overall treatment response. CGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Baseline to Week 12
Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
Time Frame: Baseline to Week 12
The EQ-5D descriptive system comprised the following 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about).
Baseline to Week 12
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Time Frame: Baseline to Week 12
The SF-MPQ-2 measures both neuropathic and nonneuropathic pain. It contains a total of 22 descriptors, which are rated on an intensity scale of 0 = None, to 10 = Worst Possible.
Baseline to Week 12
Change in bone turnover markers
Time Frame: Baseline to Week 52
Bone turnover is measured from 2 biomarkers collected from peripheral blood samples: serum carboxy terminal telopeptide of collagen type I (CTX) and serum procollagen type I N terminal propeptide (s-P1NP).
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS02-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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