CRPS Clinical Study Underway


By Ed Coghlan

People who suffer from Complex Regional Pain Syndrome (CRPS) know that the pain they suffer from the disease is often intense  – and there’s no simple way to treat it.

CRPS sufferers are paying attention to a global clinical study of a drug developed by Axsome Therapeutics, a company that is developing therapies for the management of central nervous system disorders.

Dr. Randall Kaye, Chief Medical Officer at Axsome Therapeutics visited with the National Pain Report recently to talk about CRPS.

“The medical community is aware of the crucial need for better treatment of CRPS,” he said.

Axsome is currently enrolling subjects at sites across the U.S., Canada, the U.K. and Australia in a clinical study, called CREATE-1, to evaluate its experimental medication AXS-02 for the treatment of chronic pain caused by CRPS. This medication is not yet approved. AXS-02 has been granted Fast Track and Orphan Drug Designation by the U.S. Food and Drug Administration and Orphan Medicinal Product Designation.

AXS-02 is zoledronate, which is a bisphosphonate that targets the cells in the bone and helps inhibit bone density loss. The study lasts twelve weeks. A candidate would take the oral medication one time a week for six weeks.

Dr. Kaye said the best candidates for the study are people who have recently been diagnosed with CRPS, ideally within the last six months. To see is there is a clinical site near you and for more information on whether you might qualify for the study, go here.

Symptoms of CRPS include intense burning pain, dramatic changes in skin temperature, color, or texture, extreme skin sensitivity and/or swelling or stiffness in the affected area.

The Axsome study is welcomed by many CRPS advocates. A leading pain physician, Dr. Pradeep Chopra told the National Pain Report recently that more research focused on CRPS is desperately needed.

“The lack of good research is holding us back. It is a very complex condition and medicine doesn’t want to treat complex conditions because they take a lot more time and effort,” he said.

Dr. Kaye recently published a blog on the RSDSA website that talks more about CRPS and the clinical trial.


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