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

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ClinicalTrials.gov Identifier: NCT02504008
Recruitment Status : Terminated (IDMC recommended stopping study due to futility)
First Posted : July 21, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndrome Reflex Sympathetic Dystrophy Drug: AXS-02 (oral zoledronate) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 2015
Primary Completion Date : December 2017
Study Completion Date : January 2018


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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. Change in bone turnover markers [ Time Frame: Baseline to Week 12 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504008


  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
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
United States, Colorado
Denver, Colorado, United States
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
United States, Georgia
Canton, Georgia, United States
Marietta, Georgia, United States
Saint Marys, Georgia, United States, 31558
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Washington
Bellevue, Washington, United States
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Australia, New South Wales
Broadmeadow, New South Wales, Australia
Hurstville, New South Wales, Australia
Australia, Queensland
Noosa Heads, Queensland, Australia
Australia, South Australia
Welland, South Australia, Australia
Australia, Victoria
Clayton, Victoria, Australia
Australia, Western Australia
Nedlands, Western Australia, Australia
Canada, Quebec
Sherbrooke, Quebec, Canada
United Kingdom
Warrington, Cheshire, United Kingdom
Darlington, County Durham, United Kingdom
Lambeth, London, United Kingdom
Liverpool, Merseyside, United Kingdom
Norwich, Norfolk, United Kingdom
Newcastle upon Tyne, Tyne And Wear, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Axsome Therapeutics, Inc.

Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02504008     History of Changes
Other Study ID Numbers: AXS02-301
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Axsome Therapeutics, Inc.:
bisphosphonate
CRPS
RSD
non-opioid
CRPS-1
acute on chronic pain
chronic pain
zoledronic acid

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs