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The Pre-symptomatic Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

Study acronym: Pre-fALS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv33
  2. Primary and study completion dates: Dec 2027 to Dec 2037v32
  3. 3 versions Re-verified since Apr 5, 2022, no change to tracked fieldsv29-v31
  4. Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Contacts/Locations, IPDSharingv28
  5. Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
  1. Site contact updatedv26
  2. 5 versions Re-verified since Jun 8, 2017, no change to tracked fieldsv21-v25
  3. Lead sponsor: Michael Benatar to University of Miami Completion date: Dec 2027 · Study description revisedv20 Show 2 more changesShow less
    • Completion date: Dec 2027
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2019 to Dec 2027v19
  5. 3 versions Re-verified since Mar 9, 2016, no change to tracked fieldsv16-v18
  6. Eligibility criteria revised Study description expanded, about 26 words · Site contact updatedv15 Show 2 more changesShow less
    • Study description expanded, about 26 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  7. Eligibility criteria expanded, about 18 words Site contact updated · Study description expanded, about 4 wordsv14 Show 2 more changesShow less
    • Site contact updated
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study title expanded, about 1 wordv13 See this version in full on ClinicalTrials.gov ↗
  9. Enrollment target: 300 to 500 Primary completion date: Dec 2019 · Eligibility criteria expanded, about 37 words · Collaborator revisedv12 Show 3 more changesShow less
    • Primary completion date: Dec 2019
    • Eligibility criteria expanded, about 37 words
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  10. Lead sponsor: University of Miami to Michael Benatar Site contact updated · Collaborators expanded, about 3 wordsv11 Show 2 more changesShow less
    • Site contact updated
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  11. Site contact updatedv10
  12. Re-verified, no change to tracked fieldsv9
  13. Eligibility criteria revised Study description revised · Study site revisedv8 Show 2 more changesShow less
    • Study description revised
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  14. Lead sponsor: Emory University to University of Miami Study description expanded, about 1 wordv7 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  15. Enrollment target: 30 to 300 Eligibility criteria expanded, about 9 words · Study description expanded, about 7 wordsv6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  16. Eligibility criteria expanded, about 55 words Study description expanded, about 86 words · Study title shortened, about 1 wordv5 Show 2 more changesShow less
    • Study description expanded, about 86 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  17. Enrollment target: 30 Study site revisedv4 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  18. Site contact updatedv3
  19. Site contact updated Eligibility criteria shortened, about 2 words · Study title expanded, about 3 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 2 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  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.
University of Miami
242 trials monitored
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ALS
387 trials monitored
See 18 trials at risk
Pre-fALS is a prospective natural history and biomarker study of people not yet affected with ALS, but who are at genetic risk for developing ALS. The investigators aim to recruit unaffected (healthy) people from familial ALS (fALS) pedigrees in which a known genetic mutation associated with ALS has been identified; for this study, a fALS pedigree is one with two biologically related individuals who have or have had ALS and/or FTD. Individuals who may be at genetic risk for ALS and who belong to families with at least one affected family member who has tested positive for a known ALS genetic mutation may also be eligible to participate. Our goal is to study the pre-symptomatic phase, onset and progression of ALS and to learn more about genetic and environmental factors that put people at risk for developing ALS.
Trial Details
NCT Number NCT00317616
Lead Sponsor University of Miami
Collaborators: ALS Association
Conditions Amyotrophic Lateral Sclerosis
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov