CRPS Clinical Study Underway

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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Authored by: Ed Coghlan

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My name is Stormy and I have CRPS from an injury that occurred in January of this year. I live in the US and I am currently receiving IV infusions but I am looking for different treatment options. I am interested in participating


Biphosponates affect more then just bone density and play different roles in metabolism. Metabolism is both upregulated and down regaulated in painful conditions like rsd. While i would not peg my hopes on just biphosphonates for rsd- indirectly they play a role in rsd. I would also check the krebs cycle and immune sytem functioning-levels of vitamins and minerals, too

DJ Headley

I have had RSD (CRPS) since April 1992 and would willingly participate id a study.

Alison Schorger

My daughter has suffered from this for many years. This trial shouldn’t be limited to the newly diagnosed, rather it should be for patients who have had it for any length of time.
I’ve read some of the comments, and I agree – how and why would a bone density drug affect the nervous system? Are those who participate in the trial guinea pigs for a drug that has no chance of helping them, though it might help someone with osteoporosis? Will this lead to a drug that will help?


Artie- pain care is about insurers, regulators, pharmaceutical companies, medical boards- and has little to do with people in pain. And that is why people in pain are not welcome on medical boards or in regulatory bodies or in too many doctors offices. People in pain are “the problem”. People in pain are not seen as part of the solution to problems in pain care. Having said that it is clear that since everyone but people in pain have been in charge of pain care- that those in charge of pain care the problem and not the solution.
Based on how I see it- people in pain have to convince the rest of society that they are very much part of the solution and to develop and promulgate solutions to our troubled pain care system- and get government, insurers and providers to buy into the solutions of people in pain. Unfortunately too many people in pain have been and are still passive and unwilling to develop credible solutions- let alone promote them. The ones who do promote solutions- their solutions are often not much different from the status quo.


Im new to this site and after reading so many posts about pain patients suffering the common theme is that no one is listening nor understanding especially the doctors that are billing us for standard procedures yet fall short on simply hearing us. My question is WHERE AND WHO do we begin to voice our struggles too w regard to these ridiculous opiate laws created by those that only hear what they see or hear fr the enforcement side which is why the laws were made but the chronic pain patients have been left out of the equation? The laws paint everyone w the same brush? The new opiate laws actually cap the daily mgs we should stay under and or what the doctors should prescribe under yet these numerical formulas do not take into account the tolerance factor and or variations in bodywieght? I was a bodybuilder for 20yrs and weigh 260 surely bodyweight tolerance multiple injuries conditions are all variables requiring doctors discretion but a numerical formula requirement alienates doctors discretion and a host of other issues? Some meds have higher miiligrams some less but to squeeze in under this cap requires lower mg tabs that may or may not work its just archaic whats happening and the chronic pain sufferers are being victimized when those rogue doctors in florida and the pill mills is why these laws were written yet those folks are long gone now whose left? Chronic pain patients and terrified doctors and we have to eat it man surely something has to change my question is where do we begin? Id be willing to travel to washington and represent and in sure others in my shoes would too! 5 herniated discs sciatica radiculpathy spondolothesys osteoarthritis are some of the words on my paperwork but who cares i have to live function care for a child and without meds man im hurtin! Im a military vet and ret fr law enf forced out by disabling injury now what? Ive had my meds cut 5x in 5months yet no clear indication why other than new laws? Why do laws that are supposedly created supposedly by the people for the people EXCLUDE so many people most importantly doctors!

Jean Price

I’m a little confused about why a medication to treat bone density loss might be effective for the pain of CRPS! Doesn’t sound plausible to me. When this disease has so many parasympathetic nervous system effects, I wonder why that isn’t more the focus of new meds! For me, a low dose, actually the lowest dose, of Cymbalta (or the generic) works wonders to relieve the neuropathy triggered sensations and pain…and my endocrinologist swears by it for his diabetic neuropathy patient, just uses the next increase in dosage. These medications, in five to six times the strength, are often used for depression. In low doses, the only bothersome side effect I can see drowsiness, and taking it at bedtime certainly makes this a non issue. Does anyone know why this new drug for bone destiny loss would treat CRPS? Didn’t make sense to me, but health care rarely does these days!

Annette Merkley

it seems these “treatment” trials are always for people newly diagnosed or only a couple years in…why aren’t there trials for those folks that have suffered for many years with this unbelievably painful, life destroying disease?


This is more of the same inadequate and side effect riddled antipathic medicine. Modern medicine isn’t free- it is fatally stuck on treatments that do all too little to help people in pain. Researchers are quite unwilling to make an effort to find much different and better treatments. They must believe suffering from pain doesn’t require much better treatments. Their efforts are rigidified in predetermined ways and the dead weight of path dependence weighs on them(and people in pain).
Americans who care about improving pain care should call for ending antipathic research- it is too costly to develop and yields too little for people in pain.

Michele Johnson

I have suffered with this horrible diseases for for 18yrs long horrible years!! And now have in my right foot leg up to knee from a therapist that knew nothing about this. It awful that someone in the medical field was allowed to work on me…18 yrs in right upper extremities and was able to contain it there, until someone with so knowledge of the disease was allowed to work on me. Mind you I was there for nerve damage/?RSD in the left foot. I would gladly try and help in whatever way I can to help raise awareness and more funding for this horrible beast!!