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NCT04873232 · ClinicalTrials.gov registry record · Phase 3
A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy
A Phase 3 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT04873232: Completed Phase 3 study, sponsored by Helixmith Co..
NCT04873232 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04873232, a Phase 3 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study Summary
To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.
Primary Outcome
Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 be
Interventions
- OTHER Placebo
- BIOLOGICAL Engensis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2024-07-23 |
| Phase | Phase 3 |
What the finished NCT04873232 record still lists
NCT04873232 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04873232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04873232 about?
NCT04873232 is a clinical study titled "A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy". To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.
What is the current status of trial NCT04873232?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2021-05-17. Estimated completion is 2024-07-23.
What interventions are being tested in trial NCT04873232?
The interventions under investigation include: Placebo (OTHER), Engensis (BIOLOGICAL).
Who is sponsoring clinical trial NCT04873232?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04873232's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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