Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Plain-language summary

This is an extension study providing long-term follow-up of a gene therapy called Engensis (VM202) used for painful diabetic neuropathy. Patients who had previously been enrolled in the VMDN-003 study and received Engensis (VM202) or placebo could take part. It was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Helixmith Co., Ltd.

Intervention

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

Start date

2/4/2019

Estimated completion

7/24/2019

Countries

United States

Related genes

Locations

• Phoenix, United States
• Little Rock, United States
• Sacramento, United States
• San Francisco, United States
• Santa Monica, United States
• Walnut Creek, United States
• Clearwater, United States
• Gainesville, United States
• Tampa, United States
• Boston, United States
• Raleigh, United States
• Houston, United States
• Norfolk, United States
• Renton, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Were randomized and dosed in the VMDN-003 study
2. Received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study
3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent

Exclusion Criteria:

1. Were using an investigational drug or treatment
2. Were unable or unwilling to give informed consent