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Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

NCT04055090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-10-09

Study results available
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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.

Conditions

  • Painful Diabetic Neuropathy
  • Diabetic Neuropathy, Painful

Interventions

GENETIC

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

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.

DRUG

Long-Term Follow-Up of Patients who Received Placebo

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.

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John A. Kessler, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2019-07-24
Completion
2019-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055090 on ClinicalTrials.gov