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NCT03090789: FA-COMS

FA Clinical Outcome Measures

Active, enrolled Last updated 4 October 2024
What this trial tests

trial in Friedreich Ataxia in 2,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 January 2001
Primary endpoint
1 January 2030
1 January 2030

Quick facts

Lead sponsorFriedreich's Ataxia Research Alliance
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment2,000
Start date1 January 2001
Primary completion1 January 2030
Estimated completion1 January 2030
Sites14 locations across New Zealand, Canada, Australia, United States, India

Conditions studied

Sponsor

Friedreich's Ataxia Research Alliance

Who can join

Adults 4 to 80, any sex, with Friedreich Ataxia or Neuro-Degenerative Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter natural history study aims to expand the network of clinical research centers in FA, and to provide a framework for facilitating therapeutic interventions. In addition, this study will lead to the development of valid yet sensitive clinical measures crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support genetic modifier studies, biomarker studies, and frataxin protein level assessments by building a sample repository. This natural history study is no longer recruiting under this protocol NCT03090789 but remains actively recruiting under the harmonized study (UNIFAI) NCT06016946.

Publications & conference data

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

  1. Natural History of Friedreich Ataxia: Heterogeneity of Neurologic Progression and Consequences for Clinical Trial Design.
    Rummey C, Corben LA, Delatycki M, Wilmot G, et al · · 2022 · cited 53× · PMID 35817567 · DOI 10.1212/wnl.0000000000200913
  2. Predictors of loss of ambulation in Friedreich's ataxia.
    Rummey C, Farmer JM, Lynch DR. · · 2020 · cited 52× · PMID 31938785 · DOI 10.1016/j.eclinm.2019.11.006
  3. Therapeutic Prospects for Friedreich's Ataxia.
    Zhang S, Napierala M, Napierala JS. · · 2019 · cited 35× · PMID 30905359 · DOI 10.1016/j.tips.2019.02.001
  4. Propensity matched comparison of omaveloxolone treatment to Friedreich ataxia natural history data.
    Lynch DR, Goldsberry A, Rummey C, Farmer J, et al · · 2024 · cited 33× · PMID 37691319 · DOI 10.1002/acn3.51897
  5. Scoliosis in Friedreich's ataxia: longitudinal characterization in a large heterogeneous cohort.
    Rummey C, Flynn JM, Corben LA, Delatycki MB, et al · · 2021 · cited 22× · PMID 33949801 · DOI 10.1002/acn3.51352
  6. Harmonizing results of ataxia rating scales: mFARS, SARA, and ICARS.
    Rummey C, Harding IH, Delatycki MB, Tai G, et al · · 2022 · cited 15× · PMID 36394163 · DOI 10.1002/acn3.51686
  7. Test-retest reliability of the Friedreich's ataxia rating scale.
    Rummey C, Zesiewicz TA, Perez-Lloret S, Farmer JM, et al · · 2020 · cited 14× · PMID 32779859 · DOI 10.1002/acn3.51118
  8. Longitudinal changes of SARA scale in Friedreich ataxia: Strong influence of baseline score and age at onset.
    Porcu L, Fichera M, Nanetti L, Rulli E, et al · · 2023 · cited 5× · PMID 37641437 · DOI 10.1002/acn3.51886

Verify or expand the search:

Other recruiting trials for Friedreich Ataxia

Currently open trials in the same condition.

Other Friedreich's Ataxia Research Alliance trials

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Data sources for this page

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/NCT03090789.

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