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ACTIVE NOT RECRUITING

A Natural History Study to TRACK Brain and Spinal Cord Changes in Individuals with Friedreich Ataxia (TRACK-FA)

NCT04349514 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2021-02-10
Est. Completion 2025-10

Sponsor

Monash University

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04349514

The ClinicalTrials.gov registry entry for NCT04349514 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Monash University, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04349514 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Florida, Minnesota, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04349514?

The interventions under investigation include: Natural history (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04349514?

This trial is sponsored by Monash University, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial