CRPS Nationwide Clinical Trial with Neridronic Acid
 

IMPORTANT: CRPS Clinical Trial with the drug Neridronic Acid (AKA Neridronate) is being offered in different clinical sites around the US! This is a nationwide Phase III Clinical Trial for CRPS patients with one of the clinical sites being located in Sacramento at the Northern California Research Center <https://www.northerncaliforniaresearch.com/>
If interested in the Sacramento clinical site contact Iliana Rodriguez at 916-484-0500, she is the clinical trial coordinator.

I got the information for the clinical site in Sacramento by contacting the sponsor of the clinical trial, Grunenthal. Their website is <https://www.grunenthal.us/grt-web/231100010.jsp>. I just went to the contact page and filled out why I was contacting them for the Neridronate and CRPS trial, and they emailed me back. If that doesn't work you could always try contacting the Sacramento clinical site to see if they have a list of other participating doctors.

This is the same medication that is now approved in Italy, China, Taiwan, Hong Kong and Macau for CRPS.

Here is the link for the clinical trial with Neridronate for CRPS that was done in Italy: <http://rheumatology.oxfordjournals.org/content/52/3/534.full.pdf+html?hc_location=ufi>

Here is the link for a press release about the drug being offered for CRPS in other countries: <http://www.prnewswire.co.uk/news-releases/abiogen-pharma-signed-an-agreement-with-lees-pharma-for-license-distribution-and-supply-agreement-to-market-neridronic-acid-in-china-taiwan-hong-kong-and-macau-260641611.html?hc_location=ufi>

Thanks so much for this....I went to RSD hope and they have good things to say about this 'medication'.....:grouphug:

Many thanks for the info. I will disgust this with mi neurologist...

American RSD Hope was how I originally heard about this med then I just had to do the waiting game to see when the trial would start. Here is the link for the discussion about it on RSD Hope: http://www.rsdhope.org/neridronate--...for-crps1.html

Also, I forgot to mention the clinical trial is for patients with CRPS Type 1.

Too bad I've already had bisphosphonate infusions so I'm excluded.

I was dumped by my pc in the er for what 'I did to my PC" which was nothing. I can't do the study because they said I asked for a ketamine drip, which is a lie. It's all about a female exam inappropriate. Now I will never have PM or PC for RSD. I am an official Drug seeker. I just want to die. after 4 tears of bs and fighting for everything with drs and insurers. I am ruined. I was going to do the clinic but I am ruined. So I drank after 20 years of sobriety and bought pot in Colorado and got wasted. over ketamine vs opiates.
I am so suicidal. God if I only had MS or something else with no pain. I just want to disappear and forget I was born. I use to believe God loved me. I don't anymore. I think he hates me wants me to burn in this life and the next. I know I made it worse drinking. I just don't care anymore. No loving God would let you suffer this disease. Just let me die. But I will burn forever not just now. This sucks. The funny thing is this is the best I have felt in 4 years physically and the worst spiritually and emotionally. I am disillusioned with drs.

Dear Jerie,

I'm very sorry that you're in so much pain right now and in such a terrible situation regarding your treatments.

I just wanted to mention to you that we have an SOS forum here if if ever need to vent and talk about how you're feeling.

Survivors of Suicide Forum

Call someone, a friend or a relative that you are close with to come to you so that you're not alone while you're feeling so badly.
Please call a hotline number if you are feeling suicidal or call your doctor or your therapist if you have one. Call 911 if you feel you can't deal with this anymore.

If you are in the US, call National Suicide Prevention Lifeline
1-800-273-8255
to speak to a trained counselor. Use that same number and press 1 to reach the Veterans Crisis Line.

http://www.metanoia.org/suicide/

Some members have gotten help from contacting their senators or representatives - can't hurt to try. Especially after the shake ups in the VA - have to let them know that it isn't fixed yet..

This sounds very interesting.
Does anyone know how is the treatment is going to be like with Neridronic Acid?
Is it going to be infusion? pill?
What is the trial going to include?

Been there done that. My congressman was involved and then the VA scandal broke out nationally and he sacrificed me for no bad news for Nebraska VA. Believe me they are all dirty. I feel better now. I wrote the study people and told them what I did and the doctor said it's ok, it probably won't exclude me and the study doctor will see me for PM and won't rule out ketamine, so I'll try again. I get so EMO over every roadblock I encounter and I am tired of chasing treatment all over the map. I dumped the VA a long time ago, but not before they did me a lot of local damage.

Infusions.

Might do trial
 

I am in consideration for this trial. I went in and had an evaluation, signed the consent form, and had bloodwork done. Now just waiting on approval from Grunenthal, and I am scheduled for the first infusion to be June 16th. I’m pretty scared and still not sure if I should do it. There will be a lot of blood draws on each infusion day, and they won’t do a port because heparin would interfere with the trial. I’m worried about spread to my arms. I’m also worried about getting the placebo and going through all of it for nothing. But if I can help with getting this FDA approved, then I’d be happy about that. I will post an update on if I get approved and if I actually go through with it!

started trial
 

I had a cold last week, so the neridronate trial start for me was delayed until yesterday. I had the first of 4 infusions yesterday. So far I have had absolutely no side effects, so am feeling a little bummed that I probably got the placebo. I'll post another update if I see any changes in my pain or function.

Neridronic Acid Trial
 

My pain doc told me about this trial yesterday! His office, Carolina Pain Institute, is one of the locations of the trial here in the U.S. I have an appointment to be screened on Monday (29 Jun). Have done some reading online about possible side effects. SCARY. Has anyone here participated yet and if so, what was your experience? :confused:

I am not a participant, but I have read that nerexia IV therapy if administered in the first year has a very high remission rate. The Italians cite 100%. That said, Pradeep Chopra commented that the trial included people who had CRPS less than 4 months. How were the participants diagnosed so quickly? This fact did make me wonder.

On the other hand there have been successful studies using pamidronate which has a lower remission rate.

What did impress me about the nerixia study is that the placebo group was given the iv infusion after the study was completed. They, too, had 100% remission.
So months would have had to pass, before they were treated.

Also, I did read that there are few side effects, just flu like symptoms. What did you read? I also read through Italian forums, similar to this one, to see if I could find negative experiences written about nerixia IV for CRPS. I did not find one.

I would be willing to try either therapy, because I am in unbearable pain, I cannot walk, the bones in my right foot and ankle are demineralizing, but I cannot find a provider who is willing.

I had the Paget's protocol with pamidronate a little over a year ago. It was 30 mg per four hour infusion for three consecutive days for a total of 90 mg of pamidronate. My rheumatologist set it up at the cancer center at Wake Forest. (Beforehand, I had a three phase bone scan showing significant bone changes consisent with CRPS type 1.)

It helped quite a few things, most notably bone pain and cramping. I was about 15 months from the start of symptoms at the time of the infusions. I didn't have much in the way of flu like symptoms from the infusions but I was already on 30 mg of predisone a day at the time so that probably helped. I did have nausea, gastric reflux and cramping (that I treated with calcium several times a day) during and after the infusions, maybe for a week to ten days after. I didn't think it was bad. It was worth it. They did have to stop the infusions two of three days for an hour or so because of pulse and blood pressure fluctuations, dropping oxygen saturation, nausea, blurred vision and flushing. They were able to resume without incident each time when things normalized. I also have POTS and it had been interfering with procedures because of these types of symptoms. But I still got the recommended treatment.

Good luck on getting these infusions. I don't know how I lucked up to have a rheumatologist progressive enough to try them. He said he would do it again after a year if I had my jaws x-rayed and cleared for osteonecrosis. I think when all is said and done, either bisphosphonate will end up yielding good results, especially if done early in the disease. I'd probably go ahead with the pamidronate if I were to try it again just because it's been used more.

Cdwall,

Thank you for taking the time to write.

You were very lucky to find someone willing to do this for you. I had the nuclear bone scan as well, with a bright white result only in my ankle and foot. The radiologist who read it said it was not consistent with CRPS, but did not say what else it could be. My opinion is this radiologist does not know what CRPS looks like. My scan looked exactly like every CRPS scan on the Internet.

My bone pain is significant and I suffer with severe bouts of cold and numbness. I exist thanks to a heating pad, a heated blanket and a decent husband. My life has been utter crap since this started. The incidental finding of a brain aneurysm that can be coiled has put me over the edge mentally. Pradeep Chopra says that people with CRPS have fragile veins-if this is true I have to reverse CRPS before I can have surgery which requires a catheter threaded through the femoral vein.

I ordered naltrexone and starting on Thursday I am going to dilute it and help myself according to instructions I found on an Internet site.

Sadly, I have experienced the need to do something similar in the past. My very elderly mother was addicted to Xanax and her doctor did nothing to help us. Together we successfully followed an internet "weaning off Xanax protocol." It was brilliantly simple, eliminated all withdrawal symptoms, yet not one of her doctors knew about it, suggested it nor was interested afterward. :(

Hi Cowthinker,
I just finished the series of infusions yesterday. It went smoothly, except for an issue I had with one of the phlebotomists. I had to raise a stink and request someone else because she butchered me trying to do a simple blood draw and then insert the IV. Once I got the more experienced gal to do everything, it went well. There are a lot of blood draws (4-5 each infusion day), plus the IV so my arms are sore and bruised. The IV has to be placed in the opposite arm as the blood draws, so there was no way to do it all in one arm which is what I wanted because I've been having burning in my left arm. The scary side effects you read about are rare, and since I had my dental exam done, I didn't worry about it. I recommend reading the consent packet thoroughly and ask a lot of questions. I can tell you more about my experience if you want to message me.
Missy

MissyJ

Could you please tell us how you are doing since you had the infusions?

Well, I have been reluctant to post an update because I just kept hoping and hoping I would eventually see some improvements. I am three weeks past the first infusion, so I am having to come to terms with the fact that either I got the placebo, I got the drug but the dose I received wasn’t high enough, or it didn’t work on me because of my particular CRPS or duration.

I really don’t want to deter anyone from doing the trial, or discourage anyone who is already doing it. But, it has been quite a roller coaster of emotions. I did end up having some side effects the day after the first infusion, so I had my hopes up. Last week I had two days of pain being down slightly, and got my hopes up again. But now I’m back to bad pain. I don’t regret having done it because I had to at least try.

I do wish I would have paid more attention to the mg of neridronate administered in this trial. It is not near the amount given in Italy. Is that because of the FDA? Will that affect how people respond to the drug in this trial? I don’t know. I have an appointment with my pain management doctor tomorrow, so we’ll see what he thinks I should do next. It’s possible I may have to leave the trial if we decide to go on ahead with other treatments right now. (You have to keep other meds stable for 3 months to remain in the trial). If I leave the trial, my doctor can request which treatment I received from the study director if we need it. Which we will if we decide I should go for a pamidronate infusion. I’ll let you know what happens next. Thanks for checking in. :hug:
Missy

hi lovefamilypets. thanks so much for the info on trials for this new drug. i hope that it will be the drug that cures rsd. thanks again. soft hugs to all.

At a lower dose I doubt that the results will be the same.

Thank you for checking in.