NCT06016946 (UNIFAI) is a clinical trial in Friedreich Ataxia, sponsored by Friedreich's Ataxia Research Alliance.

Who is sponsoring NCT06016946?

NCT06016946 is sponsored by Friedreich's Ataxia Research Alliance.

What condition does NCT06016946 study?

NCT06016946 studies Friedreich Ataxia.

Is NCT06016946 still recruiting?

NCT06016946 is currently recruiting now. Last updated 17 June 2025.

Last reviewed 2025-06-17 · How we verify

NCT06016946: UNIFAI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

Recruiting now Last updated 17 June 2025

What this trial tests

trial in Friedreich Ataxia in 3,000 participants. Currently enrolling.

Timeline

28 June 2023

Primary endpoint
28 January 2048

28 January 2048

Quick facts

Lead sponsor	Friedreich's Ataxia Research Alliance
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	3,000
Start date	28 June 2023
Primary completion	28 January 2048
Estimated completion	28 January 2048
Sites	34 locations across France, Italy, Netherlands, New Zealand, Greece, India, Belgium, Austria

Conditions studied

Friedreich Ataxia — all drugs for Friedreich Ataxia →

Sponsor

Friedreich's Ataxia Research Alliance

Who can join

Eligibility, any sex, with Friedreich Ataxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

At-home wearable-based monitoring predicts clinical measures and biological biomarkers of disease severity in Friedreich's Ataxia.
Mishra RK, Nunes AS, Enriquez A, Profeta VR, et al · · 2024 · cited 11× · PMID 39468362 · DOI 10.1038/s43856-024-00653-1
Managing Aminotransferase Elevations in Patients with Friedreich Ataxia Treated with Omaveloxolone: A Review and Expert Opinion on Use Considerations.
Perlman S, Anheim M, Boesch S, Lewis JH, et al · · 2025 · cited 4× · PMID 40455368 · DOI 10.1007/s40120-025-00752-8
Health-Related Quality of Life in Patients with Friedreich Ataxia Using Mobility Assistive Technologies: Limited Fit of the EQ-5D-3L Mobility Dimension.
Buchholz M, Pfaff M, Iskandar A, Reetz K, et al · · 2025 · PMID 39738982 · DOI 10.1007/s40120-024-00694-7

Verify or expand the search:

Other recruiting trials for Friedreich Ataxia

Currently open trials in the same condition.

NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07508631 — Friedreich Ataxia Nerve Ultrasund · recruiting
NCT06953583 — A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich' · Phase 3 · recruiting
NCT06623890 — A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who · recruiting
NCT06054893 — A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participa · Phase 1 · recruiting

Other Friedreich's Ataxia Research Alliance trials

Trials by the same sponsor.

NCT06560346 — Understanding the Natural History Early in the Course or Presentation of Friedreich Ataxia · withdrawn
NCT03090789 — FA Clinical Outcome Measures · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06016946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Friedreich's Ataxia Research Alliance
Last refreshed: 17 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06016946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing