UW researchers are recruiting participants for a clinical trial exploring an innovative non-opioid therapy to treat painful diabetic peripheral neuropathy (PDPN). Nalini Sehgal, MD, Professor and Chair of the Division of Rehabilitation Medicine and the Director of the UW Interventional Pain Medicine Program and Pain Medicine Fellowship, is the study’s principal investigator (PI); Ali Zandieh, MD, and Collin Kreple, MD, of the UW Department of Neurology are the trial’s sub-PIs.

PDPN affects up to 30% of patients with diabetes, significantly decreasing the quality of life for those who experience the condition – causing numbness, tingling, and intense pain in the hands, feet, and lower limbs. Worse, current treatments provide little pain reduction and are frequently not well-tolerated for most PDPN patients.

A novel substance called NRD could hold the key to finding relief for these patients. NRD was discovered in a medicinal tea used in a village in Siberia to treat various illnesses and was identified as the substance in the tea most likely to result in pain reduction. Improved by researchers through chemical alterations and put into pill form, NRD was shown to be safe and well-tolerated in three Phase 1 trials. It was then tested for a Phase 2a trial, resulting in reduced pain.

To further test the safety and efficacy of NRD, the National Institutes of Health (NIH) is funding a multi-center initiative to conduct a phase 2, placebo-controlled clinical trial. Based at Massachusetts General Hospital, the study has 16 research sites nationwide – the UW School of Medicine and Public Health is the Wisconsin site. Investigators aim to recruit 122 participants from around the United States. To participate, individuals must meet the following criteria:

• Are at least 18 years old and have had Type II diabetes with PDPN for at least six months;
• Can stop other pain medications for 12 weeks, other than acetaminophen (Tylenol), as needed;
• Don’t have a history of heart attacks, heart disease, or stroke.

Study volunteers must come in for eight to nine visits over 13 weeks and will receive up to $850 for their participation. For more information or to determine if you can participate, please contact Janelle Suriaga, Clinical Research Coordinator at (608) 265-2413 or by email.

This research is a part of the NIH-funded Early Phase Pain Investigation Clinical Network (EPPIC-Net), whose mission is to “enhance pain treatment and reduce reliance on opioids with early phase clinical trials of non-addictive pain therapeutics.”