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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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