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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00552045
Registration number
NCT00552045
Ethics application status
Date submitted
30/10/2007
Date registered
1/11/2007
Date last updated
13/11/2018
Titles & IDs
Public title
Epilepsy Phenome/Genome Project
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Scientific title
Epilepsy Phenome/Genome Project: A Phenotype/Genotype Analysis of Epilepsy
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Secondary ID [1]
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CRC
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Secondary ID [2]
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1R01NS053998-01A1
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Universal Trial Number (UTN)
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Trial acronym
EPGP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Localization-related Epilepsy
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Infantile Spasms
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Lennox-Gastaut Syndrome
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Polymicrogyria
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Periventricular Heterotopias
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Condition category
Condition code
Neurological
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Epilepsy
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Other neurological disorders
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Other
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
subject - individuals with epilepsy
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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EPGP will recruit persons with specific forms of epilepsy. DNA will be isolated from participants' blood and genetic variants associated with common forms of epilepsy will be identified.
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Assessment method [1]
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Timepoint [1]
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over 4.5 years
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Eligibility
Key inclusion criteria
- Current age from 4 weeks to 60 years.
- Clear diagnosis of epilepsy, i.e., a lifetime history of two or more unprovoked
seizures.
- Age at first unprovoked seizure younger than 40 years.
- High quality clinical and laboratory data (i.e., neuroimaging, EEG) must be available
throughout the patient's history
- All patients with localization-related epilepsy (LRE) or idiopathic generalized
epilepsy (IGE) must have a first-degree relative (parent, child, or sibling) with
non-symptomatic (idiopathic or cryptogenic) epilepsy who is willing and available to
participate.
- All patients with infantile spasms (IS), Lennox-Gastaut syndrome (LGS), or
malformations of cortical development (MCD) must have both biological parents
available and willing to participate.
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Minimum age
4
Weeks
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinical and laboratory data do not allow a clear determination of whether the patient
has epilepsy, or whether the diagnosis is LRE, IGE, IS, LGS, or MCD.
- Exclusively febrile seizures or other acute symptomatic seizures.
- Identified antecedent cause of epilepsy (i.e., a structural or metabolic insult to the
CNS prior to the first unprovoked seizure, such as stroke, brain tumor, severe head
trauma, etc., or a progressive neurodegenerative disorder).
- Recognized genetic syndrome (e.g., tuberous sclerosis, neurofibromatosis, Rett's or
Angelman's syndromes) or chromosomal abnormality. (e.g., aneuploidies, unbalanced
translocations, or chromosomal deletions and duplications detectable by conventional
medical karyotyping).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2018
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Sample size
Target
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Accrual to date
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Final
4150
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3081 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Florida
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Illinois
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of California, San Francisco
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Neurological Disorders and Stroke (NINDS)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to collect detailed information about the characteristics and
genetics of a large number of individuals with epilepsy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00552045
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Daniel Lowenstein, MD
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Address
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University of California, San Francisco, Department of Neurology
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00552045
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