NCT06016946 Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study
| NCT ID | NCT06016946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Friedreich's Ataxia Research Alliance |
| Condition | Friedreich Ataxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2048-01-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-06-28 with a primary completion date of 2048-01-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project is a global, multicenter, prospective, longitudinal, observational natural history study that can be used to understand the disease progression and support the development of safe and effective drugs and biological products for Friedreich ataxia.
Eligibility Criteria
Inclusion Criteria: 1. Both males and females of any age 2. Individuals with Friedreich ataxia (FA): Participants that meet genetically confirmed diagnosis of Friedreich ataxia 3. Written informed consent provided 1. Informed consent must be obtained for all participants 2. For underage participants, they and the parent/ legally authorized representative have to sign the informed consent form, child assent (if applicable) 3. Persons who are not legally competent require the informed consent of their legally authorized representative Exclusion Criteria: 4. Unable or unwilling to provide informed consent 5. Acute or ongoing medical or other conditions that would interfere with the conduct and assessments of the study 6. For any reason in the opinion of the investigator, participant would be unlikely or unable to comply with study protocol requirements.
Contact & Investigator
David Lynch, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT06016946 clinical trial?
This trial is open to participants of all sexes, studying Friedreich Ataxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06016946 currently recruiting?
Yes, NCT06016946 is actively recruiting participants. Contact the research team at cait.monette@cureFA.org for enrollment information.
Where is the NCT06016946 trial being conducted?
This trial is being conducted at Los Angeles, United States, Denver, United States, Gainesville, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT06016946 clinical trial?
NCT06016946 is sponsored by Friedreich's Ataxia Research Alliance. The principal investigator is David Lynch, MD at Children's Hospital of Philadelphia. The trial plans to enroll 3,000 participants.