Complex Regional Pain Syndrome (CRPS) was recently designated as a rare disorder by the United States Food & Drug Administration. A disease is considered rare if fewer than 200,000 people in the United States have it. This designation has already generated much greater interest than ever before in CRPS/RSD and is enticing pharmaceutical corporations to consider developing medicines to treat CRPS. An international clinical trial in CRPS is recruiting right now.
Now Enrolling: Phase 3 CRPS Clinical Trial of an Oral Non‐Opioid Investigational Medication CREATE‐1 (CRPS Treatment Evaluation 1 Study) is a Phase 3 multinational, multicenter, randomized, double‐blind, placebo‐controlled trial designed to evaluate the efficacy and safety of AXS‐02 for the treatment of pain associated with CRPS. AXS‐02 is an oral, non‐opioid, investigational drug that has been granted Fast Track and Orphan Drug Designation by the U.S. FDA, and Orphan Medicinal Product Designation by the European Medicines Agency for the treatment of CRPS. AXS‐02 is not approved by the FDA. The study is enrolling patients at sites in the United States, Canada, the United Kingdom and Australia. Eligible patients must be at least 18 years of age with recently diagnosed CRPS type 1 related to a traumatic injury. Eligible patients will be randomized to receive either AXS‐02 or placebo by mouth once weekly for six weeks. The primary efficacy measure is the change in patient‐reported pain intensity at the end of Week 12. Secondary outcome measures include assessments of the change in the Brief Pain Inventory (BPI) score, Patient and Clinician Global Impression of Change (PGI‐C and CGI‐C, respectively) and other quality‐of‐life measures. More information about the CREATE‐1 study is available at www.clinicaltrials.gov. To learn about eligibility and to find a study site, patients can visit www.CRPStrial.com.
Read about a new Research Study funded by RSDSA
Stanford Current Research Studies: We have a number of research studies being conducted and we always need the help of both individuals with chronic pain, and individuals without chronic pain! The studies we are currently conducting are summarized in the table below.
TARGET Post-Approval Study (TARGET PAS): A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II
To locate clinical trials in CRPS and RSD, visit clinicaltrials.gov
To view our 20-year study, visit crpssurvey.org