Great Lakes Clinical Trials Initiates Study for Patients with CRPS

Great Lakes Clinical Trials is excited to announce the initiation of a new investigational research study for patients who have been diagnosed with Complex Regional Pain Syndrome (or CRPS).

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(CRPS), also known as reflex sympathetic dystrophy (RSD), is a long term condition that often worsens with time. It is characterized by severe pain and sensitivity, swelling, and changes in the skin.  There is currently no approved cure or treatment available for patients with CRPS.

The objective of this investigational research study is to assess the safety and tolerability of neridronic acid in subjects with CRPS. This is an open-label, single-arm study, meaning that all subjects will receive treatment with neridronic acid. There is no placebo or other comparator in this study.

As reported by Pat Anson, Editor of Pain Network News (www.painnetworknews.com):

“The U.S. Food and Drug Administration has designated neridronic acid as a potential Breakthrough Therapy for CRPS. The Breakthrough Therapy designation by the FDA came after the companies reported the results of a Phase II clinical trial showing a significant reduction in pain and symptoms of CRPS with neridronic acid treatment. The drug has already received fast track and orphan drug designations from the FDA. The agency considers a new drug as a breakthrough therapy if it is intended to treat a serious condition and if preliminary clinical evidence demonstrates substantial improvement over current treatments.”

You may be eligible to participate in this investigational research study if you:

  • have a diagnosis of CRPS
  • have moderate to severe ongoing pain related to your CRPS
  • are able to differentiate the location and intensity of your CRPS pain from any other pain you may be experiencing.

The study requires up to 11 visits to the Great Lakes Clinical Trials clinic on the north side of Chicago, over the course of 9-12 months.

Participation in research does not replace the standard medical care you may be receiving from your doctor. Instead, upon your request Great Lakes Clinical Trials clinicians will work alongside your primary doctor to communicate activities related to your participation in this research.

For more information or to see if you may be eligible to participate in this trial, please call the Great Lakes Clinical Trials CRPS team at (773) 275-3500.