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NCT03685253 · ClinicalTrials.gov registry record · Phase 1
Nicotinamide Riboside for Diabetic Neuropathy
A Phase 1 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03685253 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 10 participants.
The verdict
NCT03685253, a Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
At the current time there is no effective disease modifying therapy for diabetic neuropathy (DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density. Preclinical data supports the use of Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) as a potential therapy for diabetic neuropathy. Phase I data indicates safety in humans. This study seeks to investigate the use of Niagen® (NR) as a potential treatment for diabetic neuropathy in subjects with type 2 diabetes mellitus or impaired glucose tolerance over a 6 month period. The endpoint measures in addition to the IENFD with determine changes in clinical and electrophysiological outcomes, quality of life and biochemical measures.
Interventions
- DRUG Placebo
- DRUG Niagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2022-05-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03685253
The ClinicalTrials.gov registry entry for NCT03685253 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03685253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03685253 about?
NCT03685253 is a clinical study titled "Nicotinamide Riboside for Diabetic Neuropathy". At the current time there is no effective disease modifying therapy for diabetic neuropathy (DN). The proposed study design employs a quantifiable early measure of DN, intraepidermal nerve fiber density (IENFD), allowing for accurate assessment of actual nerve fiber density. Preclinical data support...
What is the current status of trial NCT03685253?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-01-24. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT03685253?
The interventions under investigation include: Placebo (DRUG), Niagen (DRUG).
Who is sponsoring clinical trial NCT03685253?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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