NCT05480228

EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: James P. Rathmell, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-21
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2022-07-29
• Last updated: 2026-03-19

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study