Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration

NCT03912220 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00210072
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Nicotinamide Riboside

EXPERIMENTAL

Experimental group of participants will receive Nicotinamide riboside at a dose of 900 mg twice a day orally.

Drug: Nicotinamide riboside

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.

Drug: Placebo Oral Tablet

Interventions

Nicotinamide riboside DRUG

The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration.

Nicotinamide Riboside

Placebo Oral Tablet DRUG

Placebo drug that looks like the experimental drug, nicotinamide riboside tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65
• BMI\<32
• Normal neurological examination defined as Neuropathy Impairment Score \<2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Adelson Medical Research Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Small Fiber Neuropathy

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Ahmet Hoke
• Organization: Johns Hopkins University

ahoke1@jh.edu

410-955-2227

Study Officials

• Ahmet Hoke

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: September 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 30, 2023
• Last Updated: June 12, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)