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Natural History Study of and Genetic Modifiers in Spinocerebellar Ataxias

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Lead sponsor: University of Florida to Lauren Moorev29 Show 11 more changesShow less
    • Enrollment target: 800 to 1400
    • Primary and study completion dates: May 19, 2024 to Dec 2030
    • Primary endpoints: 2 to 4
    • Study sites: 12 to 17
    • Interventions: All Participants (Genetic) to Assessments and Questionnaires (Other), Blood Collection (Other), Cerebrospinal Fluid Collection (Other), Genetic Testing (Genetic)…
    • Eligibility criteria expanded, about 90 words
    • Secondary endpoints: 1 to 8
    • Study description expanded, about 24 words
    • Collaborators: 2 to 18
    • Publications expanded, about 530 words
    • Study arms: 4 to 3
  2. Primary and study completion dates: May 2022 to May 19, 2024v28
  3. Re-verified, no change to tracked fieldsv27
  4. Primary and study completion dates: May 2021 to May 2022v26
  5. Primary and study completion dates: Jul 2020 to May 2021v25
Show 23 earlier versionsHide 23 earlier versions
  1. Site contacts updated at 1 of 12 sitesv24
  2. Primary and study completion dates: Jul 2019 to Jul 2020v23
  3. Re-verified, no change to tracked fieldsv22
  4. Primary and study completion dates: Jun 2018 to Jul 2019
    • Site details revised at 1 of 12 sites
    v21
  5. Primary and study completion dates: Jun 2017 to Jun 2018v20
  6. Re-verified, no change to tracked fieldsv19
  7. Site contacts updated at 1 of 12 sites
    • Collaborators expanded, about 8 words
    v18
  8. Site details revised at 5 of 12 sitesv17
  9. Primary and study completion dates: Jun 2015 to Jun 2017
    • Study description shortened, about 122 words
    • Site details revised at 2 of 12 sites
    v16
  10. Primary and study completion dates: Jan 2015 to Jun 2015v15
  11. Re-verified, no change to tracked fieldsv14
  12. Study completion date: Jan 2018 to Jan 2015
    • Interventions: All Participants (Genetic)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site contacts updated at 5 of 12 sites
    v13
  13. Re-verified, no change to tracked fieldsv12
  14. Collaborators shortened, about 8 wordsv11
  15. Study description expanded, about 392 wordsv10
  16. Study sites: 11 to 12v9
  17. Re-verified, no change to tracked fieldsv8
  18. Site contacts updated at 3 of 11 sitesv7
  19. Site details revised at 1 of 11 sitesv6
  20. Study sites: 10 to 11v5
  21. Site details revised at 3 of 10 sitesv4
  22. Study sites: 1 to 10v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2010 to Apr 2010
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Spinocerebellar ataxias (SCA) are genetic neurological diseases that cause imbalance, poor coordination, and speech difficulties. There are different kinds of SCAs and this study will focus on types 1, 2, 3, 6, 7, 8, 10, 27B, and RFC1-ataxia (SCA 1, SCA 2, SCA 3, also known as Machado-Joseph disease, SCA 6, SCA 7, SCA 8, SCA 10, SCA27B, and RFC1-ataxia, also known as CANVAS). The diseases are rare, slowly progressive, cause increasingly severe neurological difficulties, and are variable across and within genotypes. The purpose of this research study is to bring together a group of experts in the field of SCA for the purpose of learning more about the disease. The research questions are: 1. How do these diseases progress over time? 2. What are the best ways to measure the progression? 3. Do some genes, other than the gene that is abnormal in these diseases, have any effect on the way the disease behaves? This is a nationwide study and the investigators expect that 1400 patients will participate all over North America. The participants will remain in the study for an indeterminate period of time, for as long as they are willing to participate. Study visits will be done every 12 months. Within the broader CRC-SCA, there is an Imaging Sub-study aiming to identify magnetic resonance imaging (MRI) markers sensitive to the onset and progression of common SCAs. To accomplish this, participants attend annual visits involving a neurological exam, surveys, a blood draw, and an MRI scan. Participants can attend visits at one of three US locations - Minneapolis, MN; Gainesville, FL; or Dallas, TX and two European locations - Paris, France and Bonn, Germany. Eligible participants must either have SCA1, 2, or 3 or have been a participant of the previous READISCA study (NCT03487367). Gene-positive participants must have a SARA score less than 10; however, there is no SARA limit for participants previously enrolled in READISCA. All participants must be 18 years or older. Gene-negative participants should be 25-65 years old.
Trial Details
NCT Number NCT01060371
Lead Sponsor Lauren Moore
Collaborators: University of California, Los Angeles, University of South Florida, National Ataxia Foundation, Columbia University, Johns Hopkins University, University of Texas Southwestern Medical Center, The Methodist Hospital Research Institute, University of California, San Francisco, University of Florida, Emory University, University of Chicago, Northwestern University, University of Michigan, University of Minnesota, Massachusetts General Hospital, Centre hospitalier de l'Université de Montréal (CHUM), University of Pennsylvania, University of Washington
Conditions
(from sponsor)		 Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 7, Spinocerebellar Ataxia Type 8, Spinocerebellar Ataxia Type 10, RFC1 Gene Mutation +2 more
Related terms Machado-Joseph Disease, Spinocerebellar Ataxia 10, Spinocerebellar ataxia 8, Spinocerebellar Ataxias
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov