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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: Completed Phase 1 study, sponsored by Helixmith Co..
NCT01002235 is a Phase 1 study that has completed, run by Helixmith Co.. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-emergent adverse events are any adverse events that occurred after the first dose of Engensis (VM202). This is a dose escalation study. Cohorts of increasing dose will be enrolled sequentially. Dose escalation decisions (permission to treat at higher doses) will be made by the Data Safety Monitoring Board based on review of adverse events and on the occurrence of dose limiting toxicities in each cohort. The decision to proceed to the next higher dose cohort will be made according to t
Interventions
- BIOLOGICAL VM202
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01002235 record still lists
NCT01002235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which VM202 is the first listed.
NCT01002235 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01002235's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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