The Human Epilepsy Project (HEP)
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|ClinicalTrials.gov Identifier: NCT02126774|
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : July 6, 2021
|Condition or disease|
Epilepsy is a serious disease. It affects approximately 2.4 million Americans, with a lifetime risk estimated at 3%. More than 181,000 Americans develop epilepsy every year, and a substantial proportion has seizures that cannot be controlled by available medications. For the vast majority of patients with epilepsy, we do not understand the biological basis of their disease; we do not know whether a given anti-epileptic drug (AED) will be effective; and we cannot predict the severity of the seizure disorder, the potential emergence of co-morbidities, or the likelihood of remission.
The Human Epilepsy Project seeks to answer these unknowns by collecting high-resolution clinical information and treatment response, MRIs, EEGs, and blood and urine samples for biomarkers. A major outcome of the project is to create an open data repository of clinical information and biologic samples for future studies.
HEP may have a transformative impact on epilepsy diagnosis and treatment by identifying critical clinical features and biomarkers at the onset of epilepsy that can be used to predict outcome and guide therapy. We hope to identify subsets of patients at high risk for pharmacoresistance who may benefit from more aggressive initial therapy and earlier consideration for surgical treatment. The existence of biomarkers that predict the likelihood of disease remission would dramatically affect treatment decisions and counseling for millions of patients.
In addition to its impact on current clinical care, the data and specimens collected in HEP, including sequential neuroimaging, electrophysiology and metabolite profiles, and banked DNA for the purpose of future genomics studies, have the potential to provide new insights into the biological basis of focal epilepsy, which will advance our efforts to discover effective treatments and cures for this disorder.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||488 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||The Human Epilepsy Project|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||July 1, 2021|
- Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response [ Time Frame: up to 36 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126774
|Principal Investigator:||Ruben Kuzniecky, MD||New York University, Comprehensive Epilepsy Center|
|Principal Investigator:||Jacqueline French, MD||New York University, Comprehensive Epilepsy Center|
|Principal Investigator:||Daniel Lowenstein, MD||University of California, San Francisco, Department of Neurology|