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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

NCT05480228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

NRD135SE.1

The double-blind treatment phase is up to 13 weeks.

OTHER

Placebo

A matching placebo will be taken for up to 13 weeks.

Sponsors & Collaborators

  • New York University

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • James P. Rathmell, MD

    lead OTHER

Principal Investigators

  • Jessica Robinson-Papp, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480228 on ClinicalTrials.gov