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Painful Diabetic Peripheral Neuropathy (PDPN) Study

Painful Diabetic Peripheral Neuropathy (PDPN) Study

The EN 21-01 study is testing a new investigational medication, called NRD135S.E1, to see if it is helpful and safe for patients with painful diabetic peripheral neuropathy. NRD135S.E1 showed a decrease in pain after 3 weeks of study treatment when compared to a placebo in a small study of 88 participants. This new study will look at one dose of NRD135S.E1, 80 mg per day. This study will compare the study drug to a placebo, a pill with no active drug. NRD135S.E1 is not yet approved by the FDA.

Study participation lasts approximately 6 months and includes at least 10 visits to the University of Washington Medical Center. You will be compensated $85 for each study visit and surveys completed, and the site will cover the cost of parking.

If interested, please call the UW DPN Study Team at 206-616-9981 or the study coordinator, Justine Marecaux, at 206-221-1538, or email dpnstudy@uw.edu. Dr. Maxwell Ma is the Site Principal Investigator for this research study at the University of Washington.

Participant Eligibility

18 years or older

Painful Diabetic Peripheral Neuropathy

Willing to come to UWMC every few weeks for 6 months to participate in the study visits


UW DPN Study Team
(206) 616-9981

Additional Study Details

Full Study Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg daily of NRD135S.E1 Versus Placebo in Adult and Elderly Participants with Painful Diabetic Peripheral Neuropathy (SERENDIPITY-1)

Study ID: Pro00063849
Start Date: 09/21/2022
End Date: 12/01/2023

Maxwell Ma, MD

Accepts Healthy Volunteers?

Study Site(s)

UWMC- Montlake

1959 NE Pacific St
Seattle, Washington 98195


Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.