Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
Public ClinicalTrials.gov record NCT04469270. 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
An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis 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 evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.
Study identification
- NCT ID
- NCT04469270
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Nov 20, 2020 (Actual)
- Primary completion
- Mar 24, 2023 (Actual)
- Completion
- Jul 31, 2024 (Actual)
- Last update posted
- Oct 9, 2025
2020 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Clinical Trials - Little Rock | Little Rock | Arkansas | 72205 | — |
| California Medical Clinic for Headache | Los Angeles | California | 90048 | — |
| Clinical Trials Research - Sacramento | Sacramento | California | 95821 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Gateway Clinical Trials, LLC | O'Fallon | Illinois | 62269 | — |
| Foot & Ankle Center of Illinois | Springfield | Illinois | 62704 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | — |
| Futuro Clinical Trials, LLC | McAllen | Texas | 78501 | — |
| ClinPoint Trials LLC | Waxahachie | Texas | 75165 | — |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | — |
| Dominion Medical Associates | Richmond | Virginia | 23219 | — |
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 NCT04469270, 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 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04469270 live on ClinicalTrials.gov.