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NAD+ Precursor Supplementation in Friedreich's Ataxia

NCT04817111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-07-17

Study results available
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Summary

The primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle bioenergetics.

Conditions

  • Friedreich Ataxia

Interventions

DRUG

MIB-626

Two (2) 500 mg Tablets, By Mouth, Daily

Sponsors & Collaborators

Principal Investigators

  • Shana E McCormack, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2022-05-19
Completion
2022-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04817111 on ClinicalTrials.gov