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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 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 101 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055090
The ClinicalTrials.gov registry entry for NCT04055090 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helixmith Co., which has 12 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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