Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Nathaniel Schuster, MD (ucsd)
Headshot of Nathaniel Schuster
Nathaniel Schuster

Description

Summary

The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.

Official Title

EPPIC-Net EN21-01 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.

Details

This ISA describes a double-blind Phase II study of the PK/PD, safety, tolerability, and effect of 13 weeks of NRD135S.E1 (80mg/day) as an ISA within the context of the Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy, EN21-PP. The ISA is intended to be read and interpreted within the context of the Platform Protocol and focuses on the description of design features that are specific to NRD135S.E1.

Keywords

Painful Diabetic Neuropathy, Peripheral Nervous System Diseases, Diabetic Neuropathies, Pain, NRD135SE.1, NRD135S.E1 80mg/day

Eligibility

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92037 United States
  • University of Utah School of Medicine in progress, not accepting new patients
    Salt Lake City Utah 84132 United States
  • University of Washington accepting new patients
    Seattle Washington 98195 United States

Lead Scientist at University of California Health

  • Nathaniel Schuster, MD (ucsd)
    Associate Clinical Professor, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 49 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
James P. Rathmell, MD
ID
NCT05480228
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 122 study participants
Last Updated