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PAIN-CONTROLS: Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

Peripheral Neuropathy affects over 20 million Americans. Some neuropathies are secondary to readily identifiable causes, with diabetic sensory polyneuropathy being the most common cause in the United States. Once known causes are excluded, approximately 25 to 50% remain idiopathic and are referred to as cryptogenic sensory polyneuropathy (CSPN). Neuropathic pain is a presenting symptom in 70-80% of CSPN. According to a poll obtained by the Neuropathy Association, 87% of patients rated pain management as the most challenging in managing their neuropathy. Currently there have been no prospective trials performed in the large CSPN group. The overall objective of this trial is to determine which pharmaceutical therapy is most effective and causes the fewest side effects in CSPN. To do this comparative effectiveness study, we will use an adaptive design model. The first specific aim is to determine which drug is most effective in producing pain relief and improving quality of life in patients with CSPN. We will perform a prospective randomized comparative effectiveness adaptive design study in neuropathy patients with pain who do not have diabetes and for whom no other cause has been found. The four drugs we will use are nortriptyline, duloxetine, pregabalin and mexiletine. The second specific aim is to determine which drug has the fewest and which has the most side effects. We will use the MedDRA adverse event coding system and the number of dropouts due to side effects.


 

Other Information:

  • Principal Investigator (also GPC Principal Investigator): Richard Barohn, MD; University of Kansas Medical Center
  • Participating GPC Sites:
    • University of Kansas Medical Center
  • Project Budget: $1,676,275
  • Project Period: 3 Years
  • PCORI Trial Website

 


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