Outcome Measures for Friedreich's Ataxia

(FA-COMS Trial)

Not currently recruiting at 14 trial locations
JF
CM
Overseen ByCait Monette
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Friedreich's Ataxia Research Alliance
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding Friedreich's Ataxia (FA), a rare genetic disorder affecting movement and coordination. The goal is to gather data and develop better methods to measure FA progression, aiding future treatment development. The study collects samples to support further research into genetic factors and potential biomarkers. Individuals with a confirmed FA diagnosis or those undergoing genetic testing would be suitable for this study. Participants should not have severe heart conditions, such as congestive heart failure. As an unphased trial, this study allows participants to contribute to foundational research that could lead to future breakthroughs in FA treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the FA Clinical Outcome Measures trial because it aims to develop new ways to evaluate Friedreich's Ataxia (FA), a rare genetic disease. Unlike existing treatments that focus primarily on managing symptoms, this trial is focused on identifying better measures of disease progression. By doing so, it could pave the way for more effective future therapies and improve how we track the effectiveness of new treatments. This approach is crucial because accurately understanding disease progression is key to developing targeted and timely interventions for patients with FA.

Who Is on the Research Team?

DL

David Lynch, MD PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Inclusion Criteria

Males or females age 4 to 80 years.
Genetically confirmed diagnosis of FA (for carrier/control cheek swab and blood samples this is not required).
Clinically confirmed diagnosis of FA, pending confirmatory genetic testing through a commercial or research laboratory (for carrier/control cheek swab and blood samples this is not required).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial collection of clinical measures and quality of life assessments

1 visit
1 visit (in-person)

Annual Assessment

Yearly assessments of clinical measures, quality of life, and optional sample collection

15 years
1 visit per year (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • None

Find a Clinic Near You

Who Is Running the Clinical Trial?

Friedreich's Ataxia Research Alliance

Lead Sponsor

Trials
20
Recruited
6,400+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+