A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy — REGAiN-1B  

Diabetic Peripheral Neuropathy Clinical Trial

Official title: A 6-Month Extension Study Following Protocol VMDN-003-2 - An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

Status Recruiting

Clinical Trial Summary

To evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.

Clinical Trial Description

The purpose of this 6-month extension study (VMDN-003-2b) is to evaluate the durability of efficacy and long-term safety of intramuscular (IM) administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study. No treatments will be administered in this VMDN-003-2b extension study. The combined overall duration of the VMDN-003-2 and VMDN-003-2b studies will be 12 months.

Participants will be enrolled in the VMDN-003-2b study at completion of the Day 180 Visit of Study VMDN-003-2. Participants will continue to be identified by the same Participant number and the same treatment group (Engensis or Placebo) assigned by randomization in Study VMDN-003-2. No study drug or treatment will be administered in this VMDN-003-2b extension study. The double-blind treatment assignment from the prior study will be maintained for Investigators and Participants during this extension study.

This extension study will assess the durability of efficacy and long-term safety of Engensis compared to Placebo as measured by changes in Average Daily Pain Score (ADPS) of the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN), Bedside Sensory Testing (BST), physical examinations, laboratory assessments, vital signs, treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events of special interest (AESIs). ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT04873232
• Study type: Interventional
• Source: Helixmith Co., Ltd.
• Contact: Thu Doan
• Phone: 858-815-1311
• Email: Thu.Doan@Helixmith.com
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2021
• Completion date: December 2023