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Human Epilepsy Genetics--Neuronal Migration Disorders Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary endpoint revised

    Eligibility criteria expanded, about 2 words; Study description shortened, about 4 words

    Show what changed: Primary endpoints
    Identification and characterization of genes important in normal brain development and associated with congenital brain malformations.
    Show what changed: Eligibility criteria
    INCLUSION: Males and females of any age. Persons with a brain malformation or disorder of cognition (familial intellectual disability [previously known as mental retardat [...] sons without a brain malformation or disorder of cognition (familial intellectual disability (previously known as mental retardation] or autism).
    Show what changed: Study description
    [...] makes it a realistic goal to identify genes responsible for several other epileptic conditions, related brain malformations and disorders of cognition. The purpose of this study is to identify genes responsible [...] isorders of human cognition (EDHC). The Walsh Laboratory at theBoston Children's Hospital Boston and Beth Israel Deaconess Medical Center is looking for genes involved in brain development. Conditi [...] brain malformations, such as polymicrogyria, lissencephaly, Walker-Warburg syndromepachygyria, heterotopias, microcephaly and cerebellar hypoplasia, and inherited disorders of cognition, such a [...] [...]

    Study Status, Study Description, Conditions, Outcome Measures, Eligibilityv18

  2. Notable

    Primary and study completion dates: Jun 2025 to Jun 2030

    Site contact updated

    Study Status, Contacts/Locationsv17

  3. Notable

    Primary and study completion dates: Feb 2019 to Jun 2025

    Study sites: 2 to 1; Study description shortened, about 1 word

    Show what changed: Study description
    Pediatric epilepsyEpilepsy is responsible for tremendous long-term healthcare costs. A [...]

    Study Status, Study Description, Study Design, Contacts/Locationsv16

  4. Minor

    Primary completion date: Feb 2019

    Completion date: Feb 2014 to Feb 2019; Collaborators: 1 to 2

    Show what changed: Collaborators
    Howard Hughes Medical Institute

    Study Status, Sponsor/Collaborators, Outcome Measuresv15

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v14

Show 12 earlier versions

  1. Minor

    Eligibility criteria expanded, about 10 words

    Study sites revised (2)

    Show what changed: Eligibility criteria
    INCLUSION: Males and females of any age. Persons with a brain malformation or disorder of cognition (intellectual disability [previously known as mental retardation] or autism). EXCLUSION: Persons without a brain malformation or disorder of cognition (intellectual disability (previously known as mental retardation] or autism).
    Show what changed: Study sites
    BethChildren's IsraelHospital Deaconess Medical CenterBoston, HarvardCLS15070, InstitutesWalsh of MedicineLab Children's Hospital Boston; CLS 15070

    Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locationsv13

  2. Notable

    Lead sponsor: Harvard Institutes of Medicine to Harvard University Faculty of Medicine

    Study Identification, Study Status, Sponsor/Collaboratorsv12

  3. Minor

    Completion date: Feb 2009 to Feb 2014

    Study Status, Contacts/Locationsv11

  4. Minor

    Study sites: 1 to 2

    Study description shortened, about 22 words

    Show what changed: Study description
    Pediatric epilepsy is responsible for tremendous long-term healthcare costs. Analysis of a few genetically inherited epilepticepilepsy conditions has allowed for identification of several key genes active in the developing brain. Although mostmany genetic abnormalities of the brain are rare and lethal, rap [...] sible for epilepsy and disorders of human cognition (EDHC). ManyThe ofWalsh theseLaboratory disordersat arethe dueChildren's toHospital abnormal neuronal migrationBoston and mayBeth Israel Deaconess Medical Center is looking for genes involved in brain development. Conditions that we study in [...] [...]

    Study Status, Study Description, Study Design, Contacts/Locationsv10

  5. Notable

    Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS) to Harvard Institutes of Medicine

    Collaborators expanded, about 8 words

    Show what changed: Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS)

    Study Status, Sponsor/Collaborators, Oversightv9

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  7. Minor

    Completion date: Feb 2009

    Study Status, Study Design, Eligibilityv7

  8. Minor

    Site contact updated

    Study Status, Study Design, Contacts/Locationsv6

  9. Minor

    Site contact updated

    Study Status, Eligibility, Contacts/Locationsv5

  10. Minor

    Start date: Apr 1996

    Eligibility criteria shortened, about 2 words; Study description expanded, about 23 words

    Show what changed: Eligibility criteria
    Participants are both maleINCLUSION: Males and female and may befemales of any age. TheyPersons must have, or havewith a closebrain relativemalformation with, aor disorder of neuronalcognition migration(mental retardation or autism). EXCLUSION: Persons without a brain malformation or disorder of humancognition cognition,(mental withretardation or without epilepsyautism).
    Show what changed: Study description
    [...] ultimately lead to improvements in diagnosis and treatment. Study participants must have a brain malformation or disorder of cognition (mental retardation or autism) in order to take part in this research. The long-term goal of this study is to understand the clinic [...]

    Study Identification, Study Status, Study Description, Eligibilityv4

  11. Minor

    2 amendments

    2 re-verifications since 2005-10-12, no change to tracked fields

    v2-v3

  1. Minor

    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.
The purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.
Trial Details
NCT Number NCT00041600
Lead Sponsor Harvard University Faculty of Medicine
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Howard Hughes Medical Institute
Conditions Brain Malformation, Neuronal Migration Disorder, Cognition Disorder, Epilepsy
Enrollment 3,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov