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

Diabetic Peripheral Neuropathy Clinical Trial

— REGAiN-1B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873232
• Other study ID #: VMDN-003-2b
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Helixmith Co., Ltd.
• Contact: Thu Doan
• Phone: 858-815-1311
• Email: Thu.Doan[@]Helixmith.com
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b

Exclusion Criteria:

• None

Related Conditions & MeSH terms

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

Intervention

Biological:
• Engensis
Injections with Engensis in study VMDN-003-2

Other:
• Placebo
Injections with Placebo in study VMDN-003-2

Locations

Country	Name	City	State
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Nerve and Muscle Center of Texas	Houston	Texas
United States	Clinical Trials - Little Rock	Little Rock	Arkansas
United States	California Medical Clinic for Headache	Los Angeles	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Futuro Clinical Trials	McAllen	Texas
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Gateway Clinical Trials, LLC	O'Fallon	Illinois
United States	Arizona Research Center	Phoenix	Arizona
United States	Health Concepts	Rapid City	South Dakota
United States	Dominion Medical Associates	Richmond	Virginia
United States	Clinical Trials Research - Sacramento	Sacramento	California
United States	Foot & Ankle Center of Illinois	Springfield	Illinois
United States	Richmond Behavioral Associates	Staten Island	New York
United States	ClinPoint Trials LLC	Waxahachie	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Helixmith Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of IM administration of Engensis on pain in Participants with painful DPN in the feet and lower legs as compared to Placebo	Change in the means of the Average Daily Pain Scores (ADPSs) from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome.	From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to 7 days prior to the Day 365 Visit
Secondary	To evaluate the efficacy of IM administration of Engensis on the worst pain in Participants with painful DPN in the feet and lower legs as compared to Placebo	Change in the means of the Worst Pain scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN). Maximum score = 10, minimum score = 1, higher score is a worse outcome.	From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit
Secondary	To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs	Proportion of Responders (>=50% reduction in the ADPSs from the full BPI-DPN)	From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit
Secondary	To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs	Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and clinically significant laboratory values	Day 0 to Day 365