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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA — EN21-01  

Painful Diabetic Neuropathy Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05480228
Study type Interventional
Source Massachusetts General Hospital
Contact Jean Mendez
Phone 617-548-4627
Email jmendez7@mgh.harvard.edu
Status Recruiting
Phase Phase 2
Start date September 21, 2022
Completion date January 31, 2025
View Details
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