Phase 3 Gene Therapy for Painful Diabetic Neuropathy
Public ClinicalTrials.gov record NCT02427464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 in Participants With Painful Diabetic Peripheral Neuropathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02427464
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 507 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2016 (Type not available)
- Primary completion
- Apr 2019 (Actual)
- Completion
- Apr 2019 (Actual)
- Last update posted
- Oct 9, 2025
2016 – 2019
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | — |
| Richard S. Cherlin, MD | Los Gatos | California | 95032 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Center for Clinical Research | San Francisco | California | 94115 | — |
| Neurological Research Institute | Santa Monica | California | 90404 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Associated Neurologists of Southern Connecticut, PC | Fairfield | Connecticut | 06824 | — |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | — |
| University of Florida McKnight Brain Institute | Gainesville | Florida | 32611 | — |
| UF Health College of Med, Jacksonville | Jacksonville | Florida | 32207 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | — |
| The Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Columbia University Medical Center Department of Neurology | New York | New York | 10032 | — |
| Raleigh Neurology Associates, P.A. | Raleigh | North Carolina | 27607 | — |
| Martin Foot and Ankle | York | Pennsylvania | 17402 | — |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | — |
| University of Utah -Neurology | Salt Lake City | Utah | 84132 | — |
| EVMS (Eastern Virginia Medical School) | Norfolk | Virginia | 23510 | — |
| Western Washington Medical Group | Everett | Washington | 98208 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02427464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02427464 live on ClinicalTrials.gov.