CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 (NCT02504008) | Clinical Trial Compass
UnknownPhase 3
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
United States190 participantsStarted 2015-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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