|Project #||Project Title||Research Focus Area||Research Program||Administering IC||Institution(s)||Investigator(s)||Location(s)||Year Awarded|
|A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg o.d. of NRD135S.El Versus Placebo in Adult and Elderly Subjects with Painful Diabetic Peripheral Neuropathy (SERENDIPITY-I)||Clinical Research in Pain Management||Early Phase Pain Investigation Clinical Network (EPPIC-Net)||NINDS||ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI||ROBINSON-PAPP, JESSICA||New York, NY||2021|
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
NOFO Number: OTA-20-008
People with diabetes are at risk for painful diabetic peripheral neuropathy. This pain may be experienced as burning, aching, hypersensitivity to touch, or simply as pain, and there are no currently FDA-approved medications that reduce its symptoms. This phase 2 clinical trial, through the EPPIC-NET program, will test a potential new treatment for painful diabetic peripheral neuropathy. The molecule, NRD135S.E1, is a lab-made version of a natural substance traditionally used to brew tea to treat a variety of indications, including pain, in a village in Siberia. In clinical studies, NRD135S.E1 was well tolerated by patients and showed clinically relevant pain relief. Testing within EPPIC-Net will use a master protocol, an innovative study design in which multiple treatments can be tested at the same time with fewer research participants.