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NCT04349514 · ClinicalTrials.gov registry record
A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals with Friedreich Ataxia (TRACK-FA)
A clinical trial of Friedreich Ataxia, sponsored by Monash University.
- Active
- Registry status
- 300
- Enrollment target
- 7
- Study locations
NCT04349514: Active study of Friedreich Ataxia, sponsored by Monash University.
NCT04349514 is a study of Friedreich Ataxia that is active but no longer recruiting, run by Monash University. The registered enrollment target is 300 participants, below the 428-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (30% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349514, a study of Friedreich Ataxia, is active but no longer recruiting, sponsored by Monash University.
- ACTIVE NOT RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a natural history study prospectively investigating neuroimaging markers of disease progression in children and adults with Friedreich ataxia (FA). There will be three assessment periods (baseline, 12 and 24 months). The study will include approximately 200 individuals with FA and 100 matched controls recruited across the six international academic sites. Other assessments will include secondary clinical and cognitive markers, as well as exploratory blood markers.
Primary Outcome
Magnetic susceptibility of the dentate nuclei will be measured using T2\*-weighted multiecho magnetic resonance imaging and quantitative susceptibility mapping processing. Baseline dentate nuclei susceptibility will be compared between the Friedreich ataxia and control groups. This measurement will be obtained for participants aged 11 years and over.
Conditions Studied
Interventions
- OTHER Natural history
Study Locations (7)
Florida
- University of Florida - Gainesville
Minnesota
- Center for Magnetic Resonance Research, University of Minnesota - Minneapolis
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Victoria
- Monash Biomedical Imaging, Monash University - Clayton
São Paulo
- Lab of Neuroimaging and Dept of Neurology, University of Campinas (UNICAMP) - São Paulo
Quebec
- McGill University - Montreal
Other
- Department of Neurology, RWTH Aachen University - Aachen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2025-10 |
What the registry record for NCT04349514 still lists
NCT04349514 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 428-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Friedreich Ataxia appearing as the primary indexed condition, and to 1 intervention - of which Natural history is the first listed.
NCT04349514 lists 7 locations in 7 states (Florida, Minnesota, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04349514 about?
NCT04349514 is a clinical study titled "A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals with Friedreich Ataxia (TRACK-FA)". This is a natural history study prospectively investigating neuroimaging markers of disease progression in children and adults with Friedreich ataxia (FA). There will be three assessment periods (baseline, 12 and 24 months). The study will include approximately 200 individuals with FA and 100 matche...
What is the current status of trial NCT04349514?
This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2021-02-10. Estimated completion is 2025-10.
What conditions does trial NCT04349514 study?
This clinical trial studies the following conditions: Friedreich Ataxia.
What interventions are being tested in trial NCT04349514?
The interventions under investigation include: Natural history (OTHER).
Who is sponsoring clinical trial NCT04349514?
This trial is sponsored by Monash University, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04349514 being conducted?
This trial has 7 study locations across Florida, Minnesota, Pennsylvania, Victoria, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Friedreich Ataxia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04349514's enrollment target sits among peer trials
300 3rd of 14 higher than 11 of 14 other Friedreich Ataxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Friedreich Ataxia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Clinical Course Of Disease In Participants With FA-CM
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A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
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A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
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