The Human Epilepsy Project (HEP)
HEP is a five-year, prospective, observational study whose primary goal is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with newly treated focal epilepsy.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Years|
|Official Title:||The Human Epilepsy Project|
- Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, plasma, urine
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02126774
|Contact: Sabrina Cristofarofirstname.lastname@example.org|
Show 30 Study Locations
|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|