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| Name | Class |
|---|---|
| Adelson Medical Research Foundation | UNKNOWN |
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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.
Small fiber neuropathy (SFN) is a type of peripheral neuropathy that affects the small unmyelinated fibers, including both somatic innervation of the skin and autonomic nerves. Although diabetes and prediabetes are the two most common causes, up to 50% of all SFN remain idiopathic. Currently there is no effective treatment that prevents it or reverses it through regeneration of nerve fibers.
Recent advances in understanding the molecular machinery that mediates Wallerian degeneration (i.e. degeneration of nerve fibers after physical transection) showed that key molecular players in this pathway and nicotinamide (NAD+) metabolites play a similar role in degeneration of axons in a distal-to-proximal manner seen in many peripheral neuropathies including SFN. Pre-clinical studies have shown that rapid depletion of NAD initiates a cascade of molecular events that leads to axon degeneration and that supplementation of a NAD precursor, nicotinamide riboside (NR) can prevent this degeneration.
In this study investigators plan to evaluate the ability of NR to prevent degeneration of small somatic sensory axons innervating the epidermis as well as its ability to promote regeneration of these same fibers in a human experimental model of nerve degeneration and regeneration. This experimental human model has been used previously to evaluate the rate of nerve degeneration and regeneration in several peripheral neuropathies and in healthy subjects.
Since NR is available as a nutritional supplement, if successful, this research can lead to development of a therapy for a variety of peripheral neuropathies very rapidly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide Riboside | Experimental | Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally. |
|
| Placebo | Placebo Comparator | Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide riboside | Drug | The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Denervation of Skin | Examination of degree of loss of intraepidermal nerve fibers in the skin after experimental denervation by capsaicin. The skin biopsies will be stained for a pan-axonal marker and the number of intraepidermal nerve fibers per millimeter (mm) of skin will be counted and compared to baseline skin biopsy to determine the percent change in density of intraepidermal nerve fibers. | 2 days |
| Reinnervation of Skin | Examination of degree of re-innervation of skin after experimental denervation by capsaicin. The skin biopsies will be stained for a pan-axonal marker and the number of intraepidermal nerve fibers per mm of skin will be counted and compared to epidermal nerve fiber density after capsaicin application to determine the median density of intraepidermal nerve fibers. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Hoke | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotinamide Riboside | Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally. Nicotinamide riboside: The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration. |
| FG001 | Placebo | Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug. Placebo Oral Tablet: Placebo drug that looks like the experimental drug, nicotinamide riboside tablets. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotinamide Riboside | Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally. Nicotinamide riboside: The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Denervation of Skin | Examination of degree of loss of intraepidermal nerve fibers in the skin after experimental denervation by capsaicin. The skin biopsies will be stained for a pan-axonal marker and the number of intraepidermal nerve fibers per millimeter (mm) of skin will be counted and compared to baseline skin biopsy to determine the percent change in density of intraepidermal nerve fibers. | Posted | Median | Full Range | percent change | 2 days |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotinamide Riboside | Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally. Nicotinamide riboside: The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmet Hoke | Johns Hopkins University | 410-955-2227 | ahoke1@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2020 | Apr 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071075 | Small Fiber Neuropathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
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| Placebo Oral Tablet | Drug | Placebo drug that looks like the experimental drug, nicotinamide riboside tablets. |
|
Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug. Placebo Oral Tablet: Placebo drug that looks like the experimental drug, nicotinamide riboside tablets. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Baseline intraepidermal nerve fiber density | Median | Standard Deviation | fibers/mm |
|
Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug. Placebo Oral Tablet: Placebo drug that looks like the experimental drug, nicotinamide riboside tablets. |
|
|
|
| Primary | Reinnervation of Skin | Examination of degree of re-innervation of skin after experimental denervation by capsaicin. The skin biopsies will be stained for a pan-axonal marker and the number of intraepidermal nerve fibers per mm of skin will be counted and compared to epidermal nerve fiber density after capsaicin application to determine the median density of intraepidermal nerve fibers. | Posted | Median | Full Range | intraepidermal nerve fibers per mm | 3 months |
|
|
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|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Study participants in the placebo arm will receive placebo pills that are similar in size and shape to the experimental group drug. Placebo Oral Tablet: Placebo drug that looks like the experimental drug, nicotinamide riboside tablets. | 0 | 19 | 0 | 19 | 0 | 19 |
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