CompletedPhase 3

Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

United States101 participantsStarted 2019-02-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

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

What they're measuring

Long-term Safety for Engensis Versus Placebo

Timeframe: Baseline through Day 365

Trial details

NCT IDNCT04055090

SponsorHelixmith Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-24

Results submitted2022-10-03

View on ClinicalTrials.gov More Painful Diabetic Neuropathy trials