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Global, multi-stakeholder, consortium launched to study neuroimaging biomarkers for Friedreich Ataxia

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

Downingtown, PA (September 24, 2020) - The Friedreich’s Ataxia Research Alliance (FARA) and partner organizations proudly announce an international consortium of academic, industry, and patient advocacy partners to launch a natural history study to TRACK brain and spinal cord changes in individuals with Friedreich’s ataxia (FA). Friedreich’s ataxia is a rare debilitating, life-shortening, degenerative neuro-muscular disorder. About 5,000 people in the United States and 15,000 worldwide live with FA.

The TRACK-FA study is the most extensive worldwide longitudinal, multi-center neuroimaging study in FA with 200 children and adults (and ~100 matched controls) and three assessments (baseline, 12-month, and 24-month follow-up). The TRACK-FA study aims to improve understanding of the natural disease history of FA (specifically, related to changes in the brain and spinal cord), validate neuroimaging measurements in FA to deliver a set of trial-ready biomarkers, and develop a comprehensive database to facilitate ongoing community research and discovery. The study is a collaboration between six international sites, including, Monash University (Australia), University of Minnesota (USA), Aachen University (Germany), University of Campinas (Brazil), University of Florida (USA), and the Children’s Hospital of Philadelphia (USA). FARA (USA) and several industry partners will provide input on study design, endpoints, and monitoring. The goal is to begin enrolling before the end of 2020, as individual sites are able to return to clinical research activities. Updates on opening enrollment will be shared through each of the study sites, FARA and clinicaltrials.gov, clinicaltrials.gov/ct2/show/NCT04349514

FARA CEO, Jennifer Farmer said, “TRACK-FA is a great example of public-private partnership and research advancement in the pre-competitive space. As we all need better tools to understand and measure what is happening in the FA brain and spinal cord, FARA is proud to support this international consortium. The goal of TRACK-FA is to deliver such tools for future clinical trials.”

Professor Georgiou-Karistianis from Monash University states, “We are very excited that this international collaboration brings together significant expertise in FA from across the globe. For the first time, TRACK-FA will validate neuroimaging biomarkers so that they’re ready to be pushed through the drug development pipeline. TRACK-FA provides real promise to accelerate the effort for new treatments in this rare disease.”

The study has been registered with ClinicalTrials.gov, clinicaltrials.gov/ct2/show/NCT04349514 and provides more information about TRACK-FA and a list of sites with contact information.

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