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Engensis pain treatment checked for Long-Term safety

NCT ID NCT04055090

Symptom relief Sponsor: Helixmith Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 101 people who had previously received either the experimental drug Engensis or a placebo for painful diabetic neuropathy. No new treatment was given; researchers simply monitored participants for 6 months to see if any safety issues or lasting pain relief appeared. The goal was to understand whether Engensis remains safe and effective over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Engensis (VM202)
What this could lead to
If successful, this could show that Engensis provides lasting pain relief for people with painful diabetic neuropathy.
What could go wrong
This is a follow-up study with no new treatment given, so it cannot prove effectiveness. Results depend on the original trial's outcomes, which may not be positive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

101 people

The number who actually took part.

Started

Feb 2019

Finished

Jul 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic neuropathy, painful Painful diabetic neuropathy

Contacts and locations

Locations

  • Arizona Research Center

    Phoenix, Arizona, 85023, United States

  • Center for Clinical Research

    San Francisco, California, 94115, United States

  • Clinical Research of West Florida

    Tampa, Florida, 33603, United States

  • Clinical Trials, Inc.

    Little Rock, Arkansas, 72205, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • EVMS (Eastern Virginia Medical School)

    Norfolk, Virginia, 23510, United States

  • Innovative Research of West Florida

    Clearwater, Florida, 33756, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Neurological Research Institute

    Santa Monica, California, 90404, United States

  • Northern California Research

    Sacramento, California, 95821, United States

  • Rainier Clinical Research Center, Inc.

    Renton, Washington, 98057, United States

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607, United States

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • University of Florida McKnight Brain Institute

    Gainesville, Florida, 32611, United States

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