Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

ClinicalTrials.gov ID: NCT04055090

Public ClinicalTrials.gov record NCT04055090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Long-term, Prospective, Non-interventional, Extension of a Phase III, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety & Efficacy of Engensis (VM202) in Subjects With Painful Diabetic Peripheral Neuropathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.

Study identification

NCT ID: NCT04055090
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Helixmith Co., Ltd.; Industry
Enrollment: 101 participants

Conditions and interventions

Conditions

Interventions

Genetic · Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 3, 2019
Primary completion: Jul 23, 2019
Completion: Jul 23, 2019
Last update posted: Oct 8, 2025

2019

United States locations

U.S. sites: 14
U.S. states: 9
U.S. cities: 14

Facility	City	State	ZIP	Site status
Arizona Research Center	Phoenix	Arizona	85023	—
Clinical Trials, Inc.	Little Rock	Arkansas	72205	—
Northern California Research	Sacramento	California	95821	—
Center for Clinical Research	San Francisco	California	94115	—
Neurological Research Institute	Santa Monica	California	90404	—
Diablo Clinical Research, Inc.	Walnut Creek	California	94598	—
Innovative Research of West Florida	Clearwater	Florida	33756	—
University of Florida McKnight Brain Institute	Gainesville	Florida	32611	—
Clinical Research of West Florida	Tampa	Florida	33603	—
The Brigham and Women's Hospital	Boston	Massachusetts	02115	—
Raleigh Neurology Associates, P.A.	Raleigh	North Carolina	27607	—
Nerve and Muscle Center of Texas	Houston	Texas	77030	—
EVMS (Eastern Virginia Medical School)	Norfolk	Virginia	23510	—
Rainier Clinical Research Center, Inc.	Renton	Washington	98057	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04055090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 8, 2025 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04055090 live on ClinicalTrials.gov.

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