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NCT01002235 · ClinicalTrials.gov registry record · Phase 1

Gene Therapy for Painful Diabetic Neuropathy

A Phase 1 study, sponsored by Helixmith Co..

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01002235 is a Phase 1 study that has completed, run by Helixmith Co.. The registered enrollment target is 12 participants.

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The verdict

NCT01002235, a Phase 1 study, has completed, sponsored by Helixmith Co..

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy (DPN). The study will also assess the potential of VM202 to reduce the pain associated with diabetic peripheral neuropathy.

Interventions

  • BIOLOGICAL VM202

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-02
Est. Completion 2012-04
Phase Phase 1

Sponsor

Helixmith Co.

12 total trials

What the Registry Record Tells You About NCT01002235

The ClinicalTrials.gov registry entry for NCT01002235 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 1 intervention - of which VM202 is the first listed.

NCT01002235 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01002235 about?

NCT01002235 is a clinical study titled "Gene Therapy for Painful Diabetic Neuropathy". The purpose of this open label, Phase I/II, dose-escalation, 3-cohort, multicenter, 12-month study, is to assess the safety and tolerability of injecting Engensis (VM202) in the leg muscle in patients with painful diabetic peripheral neuropathy (DPN). The study will also assess the potential of VM20...

What is the current status of trial NCT01002235?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-02. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01002235?

The interventions under investigation include: VM202 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01002235?

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.