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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 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 106 participants.

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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.

Interventions

  • OTHER Placebo
  • BIOLOGICAL Engensis

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2021-05-17
Est. Completion 2024-07-23
Phase Phase 3

Sponsor

Helixmith Co.

12 total trials

What the Registry Record Tells You About NCT04873232

The ClinicalTrials.gov registry entry for NCT04873232 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 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 Placebo is the first listed.

NCT04873232 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.