[Joe Duffer]

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