CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
NCT ID: NCT02504008
Last Updated: 2018-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
190 participants
INTERVENTIONAL
2015-07-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AXS-02 (oral zoledronate)
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
AXS-02 (oral zoledronate)
Once weekly for 6 weeks
Placebo
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Placebo
Once weekly for 6 weeks
Interventions
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AXS-02 (oral zoledronate)
Once weekly for 6 weeks
Placebo
Once weekly for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Encinitas, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Napa, California, United States
Temecula, California, United States
Denver, Colorado, United States
Clermont, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Canton, Georgia, United States
Marietta, Georgia, United States
St. Marys, Georgia, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Broadmeadow, New South Wales, Australia
Hurstville, New South Wales, Australia
Noosa, Queensland, Australia
Welland, South Australia, Australia
Clayton, Victoria, Australia
Nedlands, Western Australia, Australia
Sherbrooke, Quebec, Canada
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
Countries
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Other Identifiers
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AXS02-301
Identifier Type: -
Identifier Source: org_study_id
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