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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: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT03685253 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in the proximal thigh Intra-Epidermal Nerve Fiber Density as assessed by skin biopsy. Smaller values indicate worse neuropathy. Normative ranges depend on age and gender.
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 |
Why NCT03685253 stopped before completion
NCT03685253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03685253 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03685253's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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