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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 is a Phase 3 study that has completed, run by Helixmith Co.. The registered enrollment target is 507 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02427464
The ClinicalTrials.gov registry entry for NCT02427464 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 507 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.
NCT02427464 reports 0 study locations.
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.
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