← Back to Search

Gene Therapy

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

Phase 3
Waitlist Available
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
Pivotal Trial

Summary

This trial is studying the effects and safety of Engensis, a muscle injection treatment, for patients with Diabetic Peripheral Neuropathy, who suffer from chronic nerve pain due to diabetes. The goal is to see if Engensis can provide lasting pain relief and improve nerve function.

Eligible Conditions
  • Diabetic Neuropathy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,380 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
~56 spots leftby Dec 2025