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NCT07635030

GABA and GSH in FRDA

Enrolling by Invitation
Not specifiedAges 8–16Observational
Children's Hospital of Philadelphia
~60 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
GABA Assessment
Measured over 3 years
+3 more outcomes measured

Conditions

Friedreich's Ataxia
FRDA

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Friedreich AtaxiaFrataxin, Mitochondrial

NCT07635030

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Age ≥ 8 years; \<16 years
Written informed consent provided
Balletic Guanine-adenine-adenine (GAA) trinucleotide repeat length \> 55 in intron 1 of Frataxin (FXN) and/or GAA repeat length \> 55 in intron 1 of FXN in one allele and another type of mutation that is inferred to cause loss of function in the second FXN allele as documented in the medical record
Friedreich's Ataxia Rating Scale (FARS) Functional staging score of ≤ 5\^ and total modified Friedreich's Ataxia Rating Scale (mFARS) score of ≤ 65 on enrolment

Exclusion

Age \< 8 years \> 16 years
Acute or ongoing medical or other conditions that is deemed to interfere with the conduct and assessments of the study
Other psychiatric or neurologic conditions apart from FRDA that, in the opinion of the Site Investigator, would interfere with the conduct and assessments of the study
MR contraindications (e.g., pacemaker or other metallic surgical implants)
Presence of metallic dental braces
Currently pregnant participants
Confined to wheelchair or bed with total dependency for all activities of daily living. Total disability.
Unable to understand English instruction

What this trial measures

  • GABA Assessment3 years

    The primary study outcome measure will be obtaining gamma-aminobutyric acid (GABA) assessment derived from magnetic resonance spectroscopy (MRS) recording, to be used as a potential biomarker in patients with FRDA prior to and after taking Omaveloxolone.

  • Changes in NAA3 years

    Changes in MRS metabolite levels, including N-acetyl-aspartate (NAA)will be assessed in FRDA participants.

  • GSH Assessment3 years

    The primary study outcome measure will be obtaining glutathione (GSH) assessment derived from magnetic resonance spectroscopy (MRS) recording, to be used as a potential biomarker in patients with FRDA prior to and after taking Omaveloxolone.

  • Changes in MRS metabolite levels (Changes in ml)3 years

    Changes in MRS metabolite levels, including myo-inositol (mI) will be assessed in FRDA patients.