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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 is a Phase 3 study of Diabetic Neuropathy, Painful that has completed, run by Helixmith Co.. The registered enrollment target is 162 participants. The trial reports 16 study locations across 10 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04469270
The ClinicalTrials.gov registry entry for NCT04469270 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 162 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 1 condition, with Diabetic Neuropathy, Painful appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04469270 reports 16 study locations spanning 10 distinct geographic areas - top geographies include 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.
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