Phase 2
N=45
Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration
Small Fiber Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03912220 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Denervation of Skin — 0.1; 0.1 percent change — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nicotinamide riboside (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Denervation of Skin |
0.1; 0.1 | 0.33 |
| PRIMARY Reinnervation of Skin |
7.4; 7.3 | 0.54 |
Summary
This study will evaluate the effects of a nutritional supplement called nicotinamide riboside in preventing small fiber nerve degeneration that is experimentally induced by applying capsaicin to skin in otherwise healthy study participants. Furthermore, the effects on nerve regeneration will also be evaluated. The results will be compared to a placebo control drug.
Eligibility Criteria
Inclusion Criteria
- Age: 18-65
- BMI<32
- Normal neurological examination defined as Neuropathy Impairment Score <2
Exclusion Criteria
- History of peripheral neuropathy
- Any peripheral neuropathy risk factor including diabetes, Vitamin B12 deficiency, HIV-infection, chronic kidney or hepatic disease, hypothyroidism, chemotherapy or other know neurotoxic exposure.
Data sourced from ClinicalTrials.gov (NCT03912220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.