Engensis for Diabetic Neuropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetic NeuropathyEngensis - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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

Day 365
To evaluate the safety of IM administration of Engensis in Participants with painful DPN in the feet and lower legs
Day 365
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
Day 365
To evaluate the efficacy of IM administration of Engensis on reducing pain in Participants with painful DPN in the feet and lower legs
Day 365
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Engensis
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

250 Total Participants · 2 Treatment Groups

Primary Treatment: Engensis · Has Placebo Group · Phase 3

Engensis
Biological
Experimental Group · 1 Intervention: Engensis · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Engensis
2021
Completed Phase 2
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Virginia33.3%
Pennsylvania22.2%
California11.1%
Other33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Innovative Research of West Florida, Inc.16.7%
Clinical Trials - Little Rock16.7%
Manassas Clinical Research Center33.3%
Other33.3%
What portion of applicants met pre-screening criteria?
Did not meet criteria42.9%
Met criteria57.1%
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Clinical Trials - Little Rock: < 48 hours
Average response time
  • < 2 Days