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NCT04469270 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
A Phase 3 study of Diabetic Neuropathy, Painful, sponsored by Helixmith Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 162
- Enrollment target
- 16
- Study locations
NCT04469270: Completed Phase 3 study of Diabetic Neuropathy, Painful, sponsored by Helixmith Co..
NCT04469270 is a Phase 3 study of Diabetic Neuropathy, Painful that has completed, run by Helixmith Co.. The registered enrollment target is 162 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04469270, a Phase 3 study of Diabetic Neuropathy, Painful, has completed, sponsored by Helixmith Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 162 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Primary Outcome
• The Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy has a minimum score of 0 and a maximum score of 10, with a higher score representing a worse outcome of more pain. Change in Baseline to Day 180. Summary of the Actual Value of the Change from Baseline to Day 180 in Average Daily Pain Score (Intent-To-Treat Population). Overall Engensis n=79.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Engensis
Study Locations (16)
Texas
- Nerve and Muscle Center of Texas - Houston
- Futuro Clinical Trials, LLC - McAllen
- ClinPoint Trials LLC - Waxahachie
Virginia
- Manassas Clinical Research Center - Manassas
- Eastern Virginia Medical School - Norfolk
- Dominion Medical Associates - Richmond
California
- California Medical Clinic for Headache - Los Angeles
- Clinical Trials Research - Sacramento - Sacramento
Illinois
- Gateway Clinical Trials, LLC - O'Fallon
- Foot & Ankle Center of Illinois - Springfield
Arizona
- Arizona Research Center - Phoenix
Arkansas
- Clinical Trials - Little Rock - Little Rock
Florida
- Innovative Research of West Florida, Inc. - Clearwater
Missouri
- Clinical Research Professionals - Chesterfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 3 |
What the finished NCT04469270 record still lists
NCT04469270 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (79% lower).
The record links to 1 condition, with Diabetic Neuropathy, Painful appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04469270 lists 16 locations in 10 states (Texas, Virginia, California).
Frequently Asked Questions
What is clinical trial NCT04469270 about?
NCT04469270 is a clinical study titled "Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy". 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 th...
What is the current status of trial NCT04469270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 162 participants. The study started on 2020-11-20. Estimated completion is 2024-07-31.
What conditions does trial NCT04469270 study?
This clinical trial studies the following conditions: Diabetic Neuropathy, Painful.
What interventions are being tested in trial NCT04469270?
The interventions under investigation include: Placebo (OTHER), Engensis (BIOLOGICAL).
Who is sponsoring clinical trial NCT04469270?
This trial is sponsored by Helixmith Co., which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04469270 being conducted?
This trial has 16 study locations across Arizona, Arkansas, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Neuropathy, Painful
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04469270's enrollment target sits among peer trials
162 1474th of 2000 higher than 523 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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