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GABA and GSH in FRDA

NCT07635030 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-06-09

No results posted yet for this study

Summary

The goal of this study is to obtain gamma-aminobutyric acid (GABA) and glutathione (GSH) assessment derived from magnetic resonance spectroscopy (MRS), to be used as a potential biomarker in patients with Friedreich Ataxia (FRDA) prior to (Aim 1), and after taking Omaveloxolone (Aim 2). Analysis will consist of:

A. Comparison of values in controls with those of FRDA patients (Aim 1) B. Longitudinal comparison of values in FRDA patients repeated after Omaveloxolone administration at 3 time points (minimum of 6 months) (Aim 2)

FRDA participants will be asked to complete an MRS scan at 3 timepoints in order to observe GABA and GSH activity.

Conditions

Interventions

OTHER

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Subjects will undergo an MRI scan wherein the investigator will use a published, but recently developed, MRS protocol (HERMES) for simultaneous assessment of GABA and glutathione (GSH) in a single scan using a 3T MR scanner

Sponsors & Collaborators

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2028-06-30
Completion
2030-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT07635030 on ClinicalTrials.gov