CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Long-Term Follow-Up of Patients who Received Engensis (VM202) +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04055090
NCT04055090Phase 3Completed
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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

Helixmith Co., Ltd.·interventional·Posted Aug 13, 2019·Updated Oct 9, 2025

In Brief

A Phase 3 clinical trial evaluating Long-Term Follow-Up of Patients who Received Engensis (VM202) and Long-Term Follow-Up of Patients who Received Placebo for Painful Diabetic Neuropathy and Diabetic Neuropathy, Painful. Completed, enrolled 101 participants across 14 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Neuropathy, Diabetic Neuropathy, Painful
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2019
Enrollment StartFeb 4, 2019
Primary CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago

Interventions

Long-Term Follow-Up of Patients who Received Engensis (VM202)genetic

No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.

Long-Term Follow-Up of Patients who Received Placebodrug

No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.