Hello members, it's been sometime since I've posted last, mainly because I'm getting along fairly well managing my idiopathic SFPN pain with gabapentin (neurontin) with no serious side effects. My current dosage is 600 mg three times per day. I feel very blessed in that regard that gabapentin fortunately works for me. Unfortunately, I know it doesn't for everyone...

I received a phone call yesterday from OHSU (Portland, Oregon), briefly explaining the trial study and asked if I would like to participate. I requested more information by email and received a Clinical Research Consent Summary.

This study is apparently co-sponsored by the University of Kansas Medical Center and PCORI (Patient-Centered Outcomes Research Institute).

Project Summary from the PCORI website:

Neuropathy is a condition that affects the peripheral nerves in the arms and legs. A person with neuropathy complains of pain, numbness, and tingling in the arms and legs. A common cause of neuropathy is diabetes, but in about 25 to 50% of the population no cause is found. We call this group cryptogenic sensory polyneuropathy (CSPN). We estimate that if neuropathy affects 20 million people in the USA, 5-10 million have CSPN. While not fatal, CSPN is disabling. We have asked patients with CSPN in our clinic, and the Neuropathy Association of America has asked patients with neuropathy nationwide what is the symptom they would most like to have a treatment for, and pain is the most consistent answer. No studies have been performed to find what treatment might be effective in controlling pain in CSPN.

We are proposing a study to look at four different drugs in patients with CSPN and plan to determine which drug is most effective: nortriptyline, duloxetine, pregabalin, or mexiletine. This study is a 3-year comparative effectiveness study with a maximum of 400 subjects using an adaptive design to determine drugs that are winners (effective) and losers (ineffective). There will be three waves of enrollment (three groups) into the study. Participants in the first group will receive one of the four medication prescribed. After enough patients complete the first wave, a loser will be dropped, and in the second wave only three medications will be studied. Results will be based primarily on how the patients feel the medication had an effect on their pain, but we will also ask patients about their numbness, tingling, weakness, fatigue and sleepiness, and loss of balance.

Our goal is to determine which of the medications tested is most effective and which causes fewer side effects, e.g., upset stomach. We will also have patients come into the office at screening, baseline, and weeks 4, 8, and 12 and will ask them to rate the amount of pain they are experiencing at that time, fill out a quality-of-life questionnaire, rate how pain and fatigue interfered with their life and their sleep, and will record any side effects from the medication.

The results from this important study will give patients and doctors meaningful, practical information to guide them in selective the drug for pain that is the most effective and has the fewest side effects. We have support from our patients, the Foundation for Peripheral Neuropathy, and our local Center for Practical Bioethics in designing this study and for the Frontiers Community Partnership for Health Committee from the clinical and translational research institute.

My question to the members: Should I participate or not, considering the fact that in my case, gabapentin is an effective pain management tool.

I'm strongly leaning against involvement because gabapentin works well for me and also the fact that mexiletine may cause arrhythmia events which I sometimes struggle with (AFIB).

If for no other reason, I'm posting this up to inform everyone that this trial is taking place in 38 locations around the United States. These locations are listed here with contact information: Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations - Full Text View - ClinicalTrials.gov

Here's the link to the PCORI info: Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS) | PCORI

Mexiletine is quite toxic. It is not used much because of this.

If you search here that word, you can read the posts of people who have tried it...and failed.

This medication is well known for burning the esophagus and in some cases very severely.

It is definitely one drug where the RISK is greater than the benefit. So do be careful.

the effectiveness of any medication for nerve pain amongst people with peripheral neuropathy, and the potential adverse effects of any particular medication are so varied and particular to individuals that i have to wonder how effective this study could be to find a ranking of possible pain alleviation medications on a broad basis.

If you already found a medication that is working for you I don't see why to participate in this research.

I would appreciate more a research examining possible causes to SFN and treatments to the causes, than researching familiar available symptomatic treatments.
And I wonder how many of those hundreds of participants in this trial could get better treatment if instead of trying these symptomatic drugs they would get a thorough investigation for the cause of their SFN, or participate in a research with more expensive drugs as IVIG.

I remember reading a post some time back about studies to test drugs based on symptoms rather then the disease. (Might have been a post from DavidHC) Of course that would be against Big Pharma because (IMO) they want the opportunity to throw as many meds as possible on each person so I doubt it will get much financial backing.

I'm so fascinated by your report. I'm also at 1800 mg/day of gabapentin (of a time-release sort, gralise) and it helps with managing pain. But barely helps, and pregabilin didn't help very well. I'm also fascinated because I'm in the Portland area also.

If it were me (and it kind of is, since I could call up OHSU and I would *like* to help with studies), I wouldn't be inclined to try it. When I was switching from gabapentin to pregabilin and back, I tried reducing my gabapentin dose and once I got to 1200 mg/day, I couldn't stand it. I'd have to go on disability in order to give it up. I'm just glad I've got a desk job and work at home.

If I were on disability and could stand being without the meagre relief that gabapentin gives me, I'd consider a study like this and giving up my only island of relief in order to give feedback on these drugs.

If you don't have responsibilities and could handle dealing with higher pain levels while you try out different therapies in the name of science, I'd salute you. Call me up, I'll ice your feet, bring you ice cream or a good meal while you further science on our behalf.

I think that none of the researchers conducting these studies would be ready to make such sacrifices themselves. They are getting salary for conducting these research, and if they get interesting results they can publish them, attend conferences and maybe get promotions.
On the other hand you don't get much from participating in such study.

I would be ready to make some sacrifices for studies that might improve my quality of life, or enables access to treatments that otherwise it is impossible (or very expensive) to get. Or if they got a great potential to advance the knowledge of our illness and it isn't too risky, painful and time consuming for me.

You should also take into account that when participating in such studies usually there are strict protocols regarding the medications and the dosage. Usually you even don't know what you are getting and it might be difficult to adjust the dosage or choose the best treatment for you without quitting the study.