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NCT04055090 · ClinicalTrials.gov registry record · Phase 3
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
A Phase 3 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT04055090: Completed Phase 3 study, sponsored by Helixmith Co..
NCT04055090 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04055090, a Phase 3 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.
Primary Outcome
Long-term (6 months) safety in terms of the incidence of Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events for Subjects who received Engensis or Placebo (in the prior VMDN-003 study)
Interventions
- GENETIC Long-Term Follow-Up of Patients who Received Engensis (VM202)
- DRUG Long-Term Follow-Up of Patients who Received Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 3 |
What the finished NCT04055090 record still lists
NCT04055090 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Long-Term Follow-Up of Patients who Received Engensis (VM202) is the first listed.
NCT04055090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04055090 about?
NCT04055090 is a clinical study titled "Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy". The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to ...
What is the current status of trial NCT04055090?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2019-02-04. Estimated completion is 2019-07-24.
What interventions are being tested in trial NCT04055090?
The interventions under investigation include: Long-Term Follow-Up of Patients who Received Engensis (VM202) (GENETIC), Long-Term Follow-Up of Patients who Received Placebo (DRUG).
Who is sponsoring clinical trial NCT04055090?
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 NCT04055090's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 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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