NotablePrimary and study completion dates: Dec 2027 to Dec 2037v32
3 versionsRe-verified since Apr 5, 2022, no change to tracked fieldsv29-v31
Study Status, Sponsor/Collaborators, Oversight, Arms and Interventions, Contacts/Locations, IPDSharingv28
Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
MinorSite contact updatedv26
5 versionsRe-verified since Jun 8, 2017, no change to tracked fieldsv21-v25
NotableLead sponsor: Michael Benatar to University of Miami
Study completion date: Dec 2027
Study description revised
v20
NotablePrimary completion date: Dec 2019 to Dec 2027v19
3 versionsRe-verified since Mar 9, 2016, no change to tracked fieldsv16-v18
MinorEligibility criteria revised
Study description expanded, about 26 words
Site contact updated
v15
MinorEligibility criteria expanded, about 18 words
Site contact updated
Study description expanded, about 4 words
v14
MinorStudy title expanded, about 1 wordv13
NotableEnrollment target: 300 to 500
Primary completion date: Dec 2019
Eligibility criteria expanded, about 37 words
Collaborator revised
v12
NotableLead sponsor: University of Miami to Michael Benatar
Site contact updated
Collaborators expanded, about 3 words
v11
MinorSite contact updatedv10
Re-verified, no change to tracked fieldsv9
MinorEligibility criteria revised
Study description revised
Study site revised
v8
NotableLead sponsor: Emory University to University of Miami
Study description expanded, about 1 word
v7
NotableEnrollment target: 30 to 300
Eligibility criteria expanded, about 9 words
Study description expanded, about 7 words
v6
MinorEligibility criteria expanded, about 55 words
Study description expanded, about 86 words
Study title shortened, about 1 word
v5
MinorEnrollment target: 30
Study site revised
v4
MinorSite contact updatedv3
MinorSite contact updated
Eligibility criteria shortened, about 2 words
Study title expanded, about 3 words
v2
Study First Submitted
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.
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.