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Vitamin B3 Derivative

Vitamin B3 Derivative for Mitochondrial Myopathy

Phase 2

Recruiting

Led By Eduardo Chini, MD, PhD

Research Sponsored by Eduardo N. Chini

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biochemically and/or genetically confirmed or confirmed primary mitochondrial myopathy based on published diagnostic criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

Study Summary

This trial looks at if taking NR supplements can help people with mitochondrial myopathy, a muscle condition. #MedicalResearch

Who is the study for?

This trial is for adults with confirmed mitochondrial myopathy who agree to use effective contraception and avoid other vitamin B3 supplements. It's not for pregnant or breastfeeding individuals, those in another drug study, or with conditions that could affect results.Check my eligibility

What is being tested?

The study tests the effects of Nicotinamide Riboside (NR), a Vitamin B3 derivative, on adult-onset symptoms of mitochondrial myopathy compared to a placebo (a substance with no therapeutic effect).See study design

What are the potential side effects?

Potential side effects may include mild gastrointestinal issues like nausea or indigestion due to high doses of vitamin B3 derivatives but specific side effects related to NR will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My muscle weakness is confirmed to be due to mitochondrial disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in 6-Minute Walk Test Performance

Secondary outcome measures

Change in isometric strength of trunk extensor muscle

Change in isometric strength of trunk flexors

Change in maximal oxygen uptake (VO2 max)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotinamide Riboside treatment groupExperimental Treatment1 Intervention

Subjects will receive vitamin B3 derivative Nicotinamide Riboside (NR) daily for 12 months

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects will receive a placebo daily for 12 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide Riboside

2022

N/A

~160

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eduardo N. ChiniLead Sponsor

Eduardo Chini, MD, PhDPrincipal InvestigatorMayo Clinic

Media Library

Nicotinamide Riboside (Vitamin B3 Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT05590468 — Phase 2

Mitochondrial Myopathy Research Study Groups: Nicotinamide Riboside treatment group, Placebo Group

Mitochondrial Myopathy Clinical Trial 2023: Nicotinamide Riboside Highlights & Side Effects. Trial Name: NCT05590468 — Phase 2

Nicotinamide Riboside (Vitamin B3 Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590468 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Nicotinamide Riboside treatment group gained regulatory approval?

"Based on the available evidence, our team at Power gave Nicotinamide Riboside treatment a rating of 2 as this is a phase 2 trial and there are studies confirming its safety but none that confirm efficacy."

Answered by AI

Are there still openings in this medical experiment that participants can join?

"As per clinicaltrials.gov, this trial is no longer recruiting volunteers as it was last updated on October 19th 2020. However, 32 other trials are currently open to participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Vitamin B3 Derivative to Treat Mitochondrial Myopathy

Eduardo N. Chini 2023. "A Study to Evaluate Vitamin B3 Derivative to Treat Mitochondrial Myopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05590468.

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