← Back to Search

Gene Therapy

Engensis for Painful Diabetic Peripheral Neuropathy (REGAiN-1B Trial)

Phase 3
Recruiting
Research Sponsored by Helixmith Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit
Awards & highlights

REGAiN-1B Trial Summary

This trial will determine if a single intramuscular (IM) administration of Engensis is safe and effective over the long term.

Eligible Conditions
  • Diabetic Neuropathy

REGAiN-1B Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the 7 days prior to the day 0 visit (study vmdn-003-2) to the 7 days prior to the day 270 visit and the 7 days prior to the day 365 visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of IM administration of Engensis on pain in Participants with painful DPN in the feet and lower legs as compared to Placebo
Secondary outcome measures
To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs
To evaluate the efficacy of IM administration of Engensis on the worst pain in Participants with painful DPN in the feet and lower legs as compared to Placebo
To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs

REGAiN-1B Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EngensisExperimental Treatment1 Intervention
Patients who have received Engensis in protocol VMDN-003-2
Group II: PlaceboPlacebo Group1 Intervention
Patients who have received Placebo in protocol VMDN-003-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Engensis
2021
Completed Phase 2
~30

Who is running the clinical trial?

Helixmith Co., Ltd.Lead Sponsor
19 Previous Clinical Trials
1,383 Total Patients Enrolled

Media Library

Engensis (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04873232 — Phase 3
Diabetic Neuropathy Research Study Groups: Placebo, Engensis
Diabetic Neuropathy Clinical Trial 2023: Engensis Highlights & Side Effects. Trial Name: NCT04873232 — Phase 3
Engensis (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873232 — Phase 3
Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT04873232 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new participants enroll in this research project at this time?

"Yes, this trial is still open for recruitment according to the latest update on clinicaltrials.gov from November 3rd, 2022. The study was first posted on May 17th, 2021 and is looking for a total of 250 individuals at 17 different sites."

Answered by AI

Are there any participating sites in North America for this trial?

"Futuro Clinical Trials in McAllen, Texas is one of many locations conducting this study. Other places include the Nerve and Muscle Center of Texas in Houston, California, Foot & Ankle Center of Illinois in Springfield, Missouri amongst 16 other sites."

Answered by AI

What is the official legal standing of Engensis in the United States?

"Engensis has received a safety score of 3 from our analysts at Power. This is because Engensis is currently in Phase 3 trials, meaning that there is both efficacy and safety data available."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Innovative Research of West Florida, Inc.
Foot & Ankle Center of Illinois
Richmond Behavioral Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
1
2

Why did patients apply to this trial?

money. treatment or cure for retinopathy. Looking for much needed relief from neuropathy.
PatientReceived no prior treatments
I would like to know if this study would help me. Because I'm having so much trouble with my Feet. Hoping this will help.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Clinical Trials - Little Rock: < 48 hours
  2. Arizona Research Center: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
2021. "A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04873232.
All > Neuropathy > Peripheral Neuropathy
~64 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top