CompletedPhase 3

Phase 3 Gene Therapy for Painful Diabetic Neuropathy

United States507 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years to ≤ 75 years
. Documented history of type I or II diabetes with current treatment control (HbA1c of ≤ 10.0% at Screening) and currently on medication for diabetes (oral, injectable, and/or insulin)
. No significant changes anticipated in diabetes medication regimen
. No new symptoms associated with diabetes within the last 3 months prior to study entry
. Diagnosis of painful diabetic peripheral neuropathy in both lower extremities
. Lower extremity pain for at least 6 months
. Visual analog scale score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Average 24 Hour Pain Score From Baseline to Day 90

Timeframe: The Pain and Sleep Interference diary was completed by participants for at least 5 assessments during a 7-day period at Screening (the mean 24-hour score was the reference/baseline score) and within 14 days prior to Day 90 visit.

Participants With at Least at 50 Percent Reduction in Average 24-hour Pain Score From Baseline to Day 90

Timeframe: Baseline to Day 90

Number of Participants With Treatment-emergent Adverse Events.

Timeframe: Baseline to Day 270

Trial details

NCT IDNCT02427464

SponsorHelixmith Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04

Results submitted2022-06-22

View on ClinicalTrials.gov More Painful Diabetic Neuropathy trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥ 18 years to ≤ 75 years
. Documented history of type I or II diabetes with current treatment control (HbA1c of ≤ 10.0% at Screening) and currently on medication for diabetes (oral, injectable, and/or insulin)
. No significant changes anticipated in diabetes medication regimen
. No new symptoms associated with diabetes within the last 3 months prior to study entry
. Diagnosis of painful diabetic peripheral neuropathy in both lower extremities
. Lower extremity pain for at least 6 months
. Visual analog scale score of ≥ 40 mm at Initial Screening (0 mm = no pain - 100 mm very severe pain)

What they're measuring

Change in the Average 24 Hour Pain Score From Baseline to Day 90

Participants With at Least at 50 Percent Reduction in Average 24-hour Pain Score From Baseline to Day 90

Timeframe: Baseline to Day 90

Number of Participants With Treatment-emergent Adverse Events.

Timeframe: Baseline to Day 270

Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria