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New Study, Medication Gives Hope to CRPS-RSD Victims


Axsome Therapeutics, Inc., a biopharmaceutical company dedicated to developing therapies for the treatment of pain and other central nervous system disorders, announced last month that the first patient has been enrolled in the CREATE-1 (CRPS Treatment Evaluation 1) study, a Phase 3 trial evaluating the effectiveness and safety of disodium zoledronate (AXS-02) in the treatment of the pain associated with complex regional pain syndrome (CRPS), also known as reflex sympathetic dystrophy (RSD).

The CREATE-1 study is expected to enroll 190 patients at sites in the U.S., Canada, Europe, and Australia. Eligible patients will be treated with either AXS-02 or a placebo, and the primary objective will be to measure the change in patient-reported pain intensity, measured with the Numerical Rating Scale.

FDA Fast Tracks AXS-02

In March 2015, the U.S. Food and Drug Administration (FDA) granted “Fast Track” designation to AXS-02 for the treatment of the pain associated with CRPS/RSD. AXS-02 is an osteoclast inhibitor being developed as an oral, non-opiod medication to treat the chronic pain. It is an investigational medication not yet approved by the FDA, and its safety and efficacy have not yet been determined.

Fast Track designation typically expedites approval by providing greater access to and more frequent communication with the FDA throughout the drug development and review process. Fast Track designation also gives Axsome Therapeutics the opportunity to potentially submit sections of the AXS-02 new drug application on a rolling basis, allowing the medication to be considered for priority review at the time of submission.


CRPS/RSD is a debilitating condition characterized by severe and chronic pain in a limb, accompanied by autonomic, sensory, motor, and trophic changes. The pain and associated loss of function results in significant and sometimes permanent disability for many patients, and there is no non-opiod drug currently approved to treat CRPS/RSD in the U.S. or the European Union.



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  1. Shelley Pittillo says:
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    Interested in taking part in the study. Would like more info

  2. Stormy Mclaughlin says:
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    My 15 year-old son has suffered from complete body RSD for almost 5 years. We are currently doing Lyrica. As a mother I am desperate to help my son unfortunately I am having issues getting him on his father’s insurance we are divorced and As of now my son only has Mississippi Medicaid which doesn’t cover outta state treatment so any good treatment he gets comes outta pocket which is hard on my family. I would be amazingly grateful to see if this could help my son.

  3. Lacey says:
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    I am very interested in this study. I live near Philadelphia Pennsylvania. I developed CRPS as a result of a traumatic car crash on 6/26/14. Please send me any information on how to be involved! Thank you!

  4. Clare Poncin says:
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    My CRPS was caught early, broken fibula, only using Gabapentin 3 times a day. Would love to be part of this study.

  5. Twyanna says:
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    I was diagnosed in 1998 been thru a lot. SCS(2) and medicine pump all removed. taking so many medications to get relief i would love to be a part of this study.

  6. Mendie says:
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    I was rx’d with RSD 10 years ago. Due to a work injury I’m with workers compensation, so they don’t approve much, I’m just a number. I’m on a multitude of medication.
    I’m Very interested in this study. Living in Mississippi. Can’t wait to hear from you.

  7. Jennifer says:
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    I am taking part in this study! I am beyond excited to help researchers determine if this can help those of us suffering from CRPS! Thanks for this article and for keeping CRPS in the spotlight!!!

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    RSD is one of the many complex pain syndromes that is embedded in the muscle system aka myofascial pain and dysfunction. Other pain syndromes in this category of pain are: Trigeminal Neuralgia, Pudendal Neuralgia, Restless Leg syndrome, IBS, TOS, Whiplash and CTS. Also incomplete and thus masqueradeing named tension headaches, Migraines, Degenerative Joint Disease arthritis, rheumatism and diabetic nerve pain. Even chronic fatigue and fibromyalgia.

    Denied by the majority in the Allopathic world of medicine and misunderstood by many even in the CAM world. This category of pain is documented in the historical archives of medicine that the treatment are all valid, vetted, safe, highly effective and restorative. ⇒ without pills or surgery.

    Clues are: If you have ongoing, invisible pain and misery; think the muscle system.
    Any stubborn array of aches, weird pains, stiffnesses, tension in the face, jaw, scalp, neck, shoulders or pelvic floor; with all blood test and MRIs normal. Even Fatigue, frustration and insomnia.

    Truth: The skeleton and nerves can not be the primarily cause of pain without a smoking gun; space occupying lesion like a tumor or growth. Those who might blame the bone or a nerve have missed a few points related to how nature, biology and the human body works.

    Pain in the muscle system can only be removed by our own natural healing forces from within. There are only 3 ways to assist in the stimulation of our own natural healing forces into action deep within the muscle bundles. All of them have something in common and that is the application of a “force” which will ignite natural healing. 1) Out-side the muscles with hands and tools. 2) Inside the muscles with thin stimulative needling. 3) Inside the muscles with hypodermic stimulative needling. Add in wellness, sleep, magnesium, heat, stretching, range of motion exercises, aerobics and you have the full spectrum of all of the safe, natural and restorative holistic healing remedies blended into your plan of action.

  9. pat says:
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    Obviously Dr Rodrigues does not have, or deal with CRPS pts. Comments like needling the muscles, using force as in using hands and tools on the muscles show that you do not understand the disease I am an RN diagnosed with CRPS 3 yrs ago . Started in my right foot after a TMA, and has now spread to above my knees in both legs, and I suspect into my lower back as well. There aren’t many pts. that can even handle anyone “touching” their affect limbs, let alone massaging!. As far as safe and effective? Needling is neither. There are numerous research articles stating that something as small as a blood draw can cause CRPS to spread, so no, I don’t think needling is safe or effective for most patients. There are plenty of holistic aids that help the patient tolerate the pain, but it very rarely goes into remission. It is a lifelong misery. If a pharm company can come up with a safe medication that at least diminishes the pain, then there is nothing wrong with patients who want to try and see if it will help them. Have some compassion DR.! You have missed a few points in your charactization of CRPS pts. We are not ignorant,uninformed, or just wanting drugs. The pain is REAL. The only sentence that I agree with is your last one. Yes we try a combo of anything that works for us. Some search for years to find relief, others never find it. I hope you treat your patients more compassionately than you seem to be stating in your response. You come off as a not so caring person, advocating “force” for treatment.

  10. Deb Murray says:
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    I’m very interested in learning more about this new program. My 17 year old daughter was diagnosed at age 13 with RSD following a sports injury to her foot. She was diagnosed within 3 week of her injury, has had extensive PT, but she has had spread to her other foot, both knees, and both hands. We fight to keep her pain free, especially on bad weather days and struggle with vibration. In just two years she will be in college and our focus is to do everything we can to assure she will be able to achieve her childhood dream of becoming a veterinarian. Thank you to everyone involved in the continued research to find better treatments for CRPS.

  11. Robert luxton says:
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    I have has CRPS for twenty years. I have had a spinal cord stimulator that is not working, I have a internal pain pump that is not working. I have tried all different nerve and pain meds with out any true success. Would like to participate in your test!

  12. James Goldman MD says:
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    Would appreciate more info on applying for the trial, please.

  13. Victoria Coffey says:
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    Its been an year since my diagnosis (RSD/CRPS) started from an injury to my right foot and has spread to other foot and both hands. This is a horrible neurological disease with the worst pain ever! I have many specialist at a great hospital but none of the treatment plans have worked for me. (Sympathic nerve injections, gabapentin, amitriplyine, neurontin, Lyrica, Terazosin, and Topamax) I would love more info on this study!

  14. BethAnne says:
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    I have full body RSD and am fully disabled from this disease. I had a brain scan where they studied the brain signals coming from the pain center…it is lit up like a Christmas tree constantly sending pain signals to my whole body. It began after a tick bite and then a major surgery to save my life. Doctor Rodigues…i have tried some of your healing practices and they put me in a flare that has never gone away. When the clothes you wear feel like they are burning your skin like a hot iron…what do you think needles will do…this is involves the muscles but it is mainly a neuroligical disorder. With more information regarding any side effects I would love to learn more about this new drug. I know of two other studies being done right now. Praying for an answer to this disease….and for anyone suffering from relentless pain. Please email me regarding participation in this trial…

  15. John Heffner says:
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    I would like to get more information on this please

  16. Ann says:
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    I would not let Dr. Rodrigues near me….he has no understanding of CRPS/RSD….

  17. Heshy Katz says:
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    My daughter has a severe case of CRPS that has been resistant to every treatment we’ve tried, & we’ve tried many over the 5 years since she got it. She also has a very extreme sensitivity to noise/vibration. We are certainly interested in this trial.

    Deb Murray, you mention that you fight to keep your daughter pain free so that she can attend school. I would like to get in touch with you to find out how you manage that as we’ve been completely unsuccessful in that regard. You can email me at fellowrsder@gmail.com.

  18. Laura says:
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    Sign me up for the trial please.

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    […] In March 2015, the U.S. Food and Drug Administration (FDA) granted “Fast Track” designation to AXS-02 for the treatment of the pain associated with CRPS/RSD. AXS-02 is an osteoclast inhibitor being developed as an oral, non-opiod medication to treat the chronic pain. It is an investigational medication not yet approved by the FDA, and its safety and efficacy have not yet been determined. Read more here… […]

  20. Lalarid says:
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    Dr. Rodrigues, with all due respect, you are a quack. That will be all.

  21. Amy says:
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    I was diagnosed w CRPS/RSD in Oct 2007 after a spinal fusion surgery that went bad and they had to perform emergency exploratory admoninal surgury to save my life. I have tried the spinal simulator 3 times, plus a varied diff amount of treatments. It has since spread throughout my body.
    Im now on a bunch of meds that have a lot of side affects & only ease my pain a bit as my pain is so severe that wearing clothes can make me feel like im living in hell.
    I live near Syracuse NY if you need someone in this area.
    P.S. Dr. Rodrigues, No!

  22. kelly says:
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    I use ooana pericet tramadol ketimine cymbalta two sleeping pulls and a SCS. I’ve had splints air casts aqua therapy physical therapy laser therapy braces dyno splints lumbar injection nerve blocks beir blocks..now awaiting on pain pump…

  23. Sandy Zingaro says:
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    I was diagnosed 10 years ago after a cervical dissection & fusion and I screamed in the recovery room if anyone touched my right hand. I have taken all different types of pain meds, all having different side effects from Lyrica making my eyesight blurry to having 2 stimulators implanted to monthly stellette ganglion nerve blocks. It has spread to both upper and lower extremities on right & left side. I would be interested in this study as long as Dr.Rodrigues has absolutely nothing to do with it.

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    Bryan Pope and I do not endorse this study, we just put information out on our blog about CRPS/RSD that we think you might be interested in. I hope this new drug will improve the quality of life for CRPS/RSD sufferers. I have been dealing with this horrific condition since the 1980s when I had workers compensation clients who had the condition. Since 95% of the CRPS/RSD cases are caused by trauma, we see quite a number in our personal injury practice. Bryan and I have been specializing in this trauma related condition for many years. I also think Dr. Rodriguez is a quack. I am sorry to say I have run into many mis-informed physicians and physical therapists who have no clue about CRPS/RSD and therefore treat the condition inappropriately.

  25. Crystal Perkins says:
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    I have a 12 year old diagnosed, suffering at a pain level 10 as well as extreme sensitive for 8 months. Given all the protocol medications, no success. Currently staying at the Children’s Institute in Pittsburgh Pa for rehabilitation . I will have to say, they aggressively worked with my daughter. we are walking on our own, out of wheelchair. Working hours daily PT, OT & PY. Unfortantly no relief from thr chronic pain & sensativity. Which has now spread to completly cover her right side of her body including her scalp. Defiantly interested in this trial. Please forward any information. Thank you.

  26. Dr. Mark W. Helfand says:
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    I was diagnosed with CRPS in 1998, two years after symptoms started in my right arm. I was misdiagnosed with Radial Tunnel Syndrome in 1996 and the pain worsened after the surgery. It caused me to retire and now it has spread to all four extremities slowly spreading medially. I too have had multiple ablation surgeries, SCS, Intrathecal pump and now take 15 mg of transmucosal fentanyl every 3 hours. It is a sad state when someone as I’ll informed as Rodreguez (I hesitate to use Dr) can torture people who are already agonized by CRPS. His “treatment” would only serve to increase the the suffering of a group of patients that deserve and need all the compassion they can get. There is no room for quackery in the treatment of CRPS.