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Phase 3 Gene Therapy for Painful Diabetic Neuropathy

NCT02427464 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2025-10-09

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy.

A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received Investigational product treatment, whereas 7 participants did not receive Investigational product treatment.

Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants

Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants

Randomization were stratified by current use of gabapentin and/or pregabalin.

Conditions

  • Painful Diabetic Neuropathy
  • Diabetic Neuropathy, Painful

Interventions

BIOLOGICAL

Engensis (VM202)

gene therapy

OTHER

placebo

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
2016-04-30
Primary Completion
2019-04-30
Completion
2019-04-30

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 NCT02427464 on ClinicalTrials.gov