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Brain Development Research Program

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary and study completion dates: Jan 2025 to Jan 2027

    Study Statusv22

  2. Minor

    2 amendments

    2 re-verifications since 2022-08-03, no change to tracked fields

    v20-v21

  3. Minor

    Study description expanded, about 2 words

    Publications: 13 to 19

    Show what changed: Study description
    [...] Dandy-Walker malformation (DWM), clinical information, and saliva or blood samples from the affected individual and from the parents. Please see contact information and our webpage below.
    Show what changed: Publications
    Edwards TJ, Sherr EH, Barkovich AJ, Richards LJ. Clinical, genetic and imaging findings identify new causes for corpus callosum development syndromes. Brain. 2014 Jun;137(Pt 6):1579-613. doi: 10.1093/brain/awt358. Epub 2014 Jan 28. Johnson-Kerner B, Snijders Blok L, Suit L, Thomas J, Kleefstra T, Sh [...]

    Study Status, Study Description, Contacts/Locations, Referencesv19

  4. Notable

    Primary and study completion dates: Jan 2020 to Jan 2025

    Study Statusv18

  5. Minor

    Study Status, Contacts/Locations, References

    Re-verified, no change to tracked fields

    v17

Show 15 earlier versions

  1. Notable

    Primary and study completion dates: Jan 2018 to Jan 2020

    Study Status, Contacts/Locationsv16

  2. Minor

    2 amendments

    2 re-verifications since 2015-12-02, no change to tracked fields

    v14-v15

  3. Minor

    Primary and study completion dates: Jan 2018

    Study description expanded, about 6 words

    Show what changed: Study description
    [...] a copy of the magnetic resonance imaging (MRI) documenting Agenesis Corpus Callosum (ACC), Polymicrogyria (PMG), or Dandy-Walker malformation (DWM), clinical information, and blood samples from the affected [...]

    Study Status, Study Descriptionv13

  4. Minor

    2 amendments

    2 re-verifications since 2012-11-13, no change to tracked fields

    v11-v12

  5. Notable

    Enrollment target: 500 to 2000

    Study Status, Sponsor/Collaborators, Study Designv10

  6. Minor

    Collaborators: 3 to 2

    Publications: 9 to 13

    Show what changed: Collaborators
    University of Chicago Fuller InstituteWashington
    Show what changed: Publications
    Travaglini L, Brancati F, Attie-Bitach T, Audollent S, Bertini E, Kaplan J, Perrault I, Iannicelli M, Mancuso B, Rigoli L, Rozet JM, Swistun D, Tolentino J, Dallapiccola B, Gleeson JG, Valente EM; International JSRD Study Group; Zankl A, Leventer R, Grattan-Smith P, Janecke A, D'Hooghe M, Sznajer Y, [...]

    Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations, Referencesv9

  7. Minor

    Publications: 1 to 9

    Show what changed: Publications
    Glass HC, Shaw GM, Ma C, Sherr EH. Agenesis of the corpus callosum in California 1983-2003: a population-based study. Am J Med Genet A. 2008 Oct 1;146A(19):2495-500. doi: 10.1002/ajmg.a.32418. Tang PH, Bartha AI, Norton ME, Barkovich AJ, Sherr EH, Glenn OA. Agenesis of the corpus callosum: an MR ima [...]

    Study Status, Sponsor/Collaborators, Study Design, Eligibility, Referencesv8

  8. Minor

    Eligibility criteria expanded, about 4 words

    Study description shortened, about 9 words; Site contact updated; Collaborators: 1 to 3; and 1 more

    Show all 5 changes in this update
    • Minor Eligibility criteria expanded, about 4 words
      Show what changed
      Inclusion Criteria: Clinical diagnosis of agenesis or dysgenesis of the corpus callosum, polymicrogyria, or Dandy-Walker malformation Should be confirmed by an MRI (Magnetic Resonance Imaging) [...]
    • Minor Study description shortened, about 9 words
      Show what changed
      We are studying both the genetics and clinical features of agenesisthese or dysgenesis of the corpus callosum and Aicardi Syndromedisorders. We hope to understand the problems faced by individuals with agenesisthese ofdisorders corpusas callosumwell (ACC)as and thetheir causes of ACC. In the future, we hope to develop therapies that are geare [...] py of the magnetic resonance imaging (MRI) documenting ACC, PMG, or DWM, clinical information, and blood samples from the affected individual with ACC and from the parents. Please see contact information and our webpage below.
    • Minor Site contact updated
    • Minor Collaborators: 1 to 3
      Show what changed
      California Institute of Technology Fuller Institute
    • Minor Study title shortened, about 6 words
      Show what changed
      AgenesisBrain of the Corpus Callosum and Aicardi SyndromeDevelopment Research ProjectProgram

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Eligibility, Contacts/Locationsv7

  9. Minor

    Study description revised

    Show what changed: Study description
    [...] sed on the underlying biology. To participate in the study, patientsyou will be asked to provide a copy of the magnetic resonance i [...]

    Study Status, Study Descriptionv6

  10. Minor

    Completion date: Sep 2006 to not stated

    Study description shortened, about 2 words

    Show what changed: Study description
    The investigatorsWe are studying both the genetics and clinical features of age [...] or dysgenesis of the corpus callosum and Aicardi Syndrome. The investigatorsWe hope to understand the problems faced by individuals with a [...] corpus callosum (ACC) and the causes of ACC. In the future, investigatorswe hope to develop therapies that are geared specifically for [...]

    Study Status, Study Description, Conditionsv5

  11. Minor

    Eligibility criteria revised

    Study description expanded, about 7 words; Study title revised

    Show what changed: Eligibility criteria
    Inclusion Criteria: Clinical Diagnosisdiagnosis of Agenesisagenesis or Dysgenesisdysgenesis of the Corpuscorpus Callosum.callosum Should be confirmed by an MRI (Magnetic Resonance Imaging) of the Brainbrain Exclusion Criteria: Fully formed but hypoplastic corpus callosum
    Show what changed: Study description
    WeThe investigators are studying both the genetics and clinical features of age [...] or dysgenesis of the corpus callosum and Aicardi Syndrome. WeThe investigators hope to understand the problems faced by individuals with agenesis of corpus callosum (ACC) and the causes of ACC. In the future, weinvestigators hope to develop therapies that are geared specifically for [...] sed on the underlying biology. To participate in the study, youpatients will be asked to provide us with a copy of the magnetic resonance imaging (MRI) documenting ACC, clinical information, and blood samples from the individual with AC [...]
    Show what changed: Study title
    Agenesis of the Corpus Callosum &and Aicardi Syndrome Research Project

    Study Identification, Study Status, Study Description, Conditions, Eligibility, Contacts/Locationsv4

  12. Minor

    Completion date: Jul 2005 to Sep 2006

    Study Status, Contacts/Locationsv3

  13. Minor

    Study description expanded, about 4 words

    Study title expanded, about 3 words

    Show what changed: Study description
    We are studying both the genetics and clinical features of agenesis or dysgenesis of the corpus callosum and Aicardi Syndrome. We hope to understand the problems faced by individuals wi [...]
    Show what changed: Study title
    Agenesis of the Corpus Callosum & Aicardi Syndrome Research Project

    Study Identification, Study Status, Study Description, Conditionsv2

  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.
Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are studying the genetic causes of disorders of cognition and epilepsy, in particular disorders of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of the investigators' research is to use a better understanding of the underlying genetic causes as a foundation to develop better treatments for these groups of patients.
Trial Details
NCT Number NCT00305305
Lead Sponsor University of California, San Francisco
Collaborators: University of Washington, California Institute of Technology
Conditions Brain Disorders, Aicardi Syndrome
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov