Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful

In brief

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.

Key facts

Study ID

NCT04055090

Run by

Helixmith Co., Ltd.

People needed

101

Starts

2019-02-04

Expected to finish

2019-07-24

Last updated by the study team

2025-10-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Were using an investigational drug or treatment
• Were unable or unwilling to give informed consent

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• Northern California Research — Sacramento, California, United States
• Center for Clinical Research — San Francisco, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• University of Florida McKnight Brain Institute — Gainesville, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• The Brigham and Women's Hospital — Boston, Massachusetts, United States
• Raleigh Neurology Associates, P.A. — Raleigh, North Carolina, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States
• EVMS (Eastern Virginia Medical School) — Norfolk, Virginia, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, United States

Full record on ClinicalTrials.gov

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