Trial Outcomes & Findings for Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration (NCT NCT03912220)

Last Updated: 2024-06-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

2 days

Results posted on

2024-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	26	19
Overall Study COMPLETED	26	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotinamide Riboside n=26 Participants 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.	Placebo n=19 Participants 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.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants
Baseline intraepidermal nerve fiber density	10.75 fibers/mm STANDARD_DEVIATION 5 • n=5 Participants	11.1 fibers/mm STANDARD_DEVIATION 3.9 • n=7 Participants	10.9 fibers/mm STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Outcome measures

Outcome measures
Measure	Nicotinamide Riboside n=26 Participants 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.	Placebo n=19 Participants 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.
Denervation of Skin	0.1 percent change Interval 0.0 to 0.8	0.1 percent change Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Nicotinamide Riboside n=26 Participants 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.	Placebo n=19 Participants 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.
Reinnervation of Skin	7.4 intraepidermal nerve fibers per mm Interval 3.0 to 12.8	7.3 intraepidermal nerve fibers per mm Interval 3.0 to 11.8

Adverse Events

Nicotinamide Riboside

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ahmet Hoke

Johns Hopkins University

Phone: 410-955-2227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place