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NCT02427464 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Gene Therapy for Painful Diabetic Neuropathy
A Phase 3 study, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 507
- Enrollment target
NCT02427464: Completed Phase 3 study, sponsored by Helixmith Co..
NCT02427464 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 507 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02427464, a Phase 3 study, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 507 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received Investigational product treatment, whereas 7 participants did not receive Investigational product treatment. Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants Randomization were stratified by current use of gabapentin and/or pregabalin.
Primary Outcome
Participants rated their 24-hour average daily pain intensity score using an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain) in a Daily Pain and Sleep Interference Diary
Interventions
- OTHER placebo
- BIOLOGICAL Engensis (VM202)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-04 |
| Phase | Phase 3 |
What the finished NCT02427464 record still lists
NCT02427464 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02427464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02427464 about?
NCT02427464 is a clinical study titled "Phase 3 Gene Therapy for Painful Diabetic Neuropathy". The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note ...
What is the current status of trial NCT02427464?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 507 participants. The study started on 2016-04. Estimated completion is 2019-04.
What interventions are being tested in trial NCT02427464?
The interventions under investigation include: placebo (OTHER), Engensis (VM202) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02427464?
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 NCT02427464's enrollment target sits among peer trials
507 739th of 2000 higher than 1,260 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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