04 Jan 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
Contact
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)
Investigator(s)
Maxwell Ma, MD
Accepts Healthy Volunteers?
No
Study Site(s)
UWMC- Montlake
1959 NE Pacific St
Seattle, Washington 98195
