The Human Epilepsy Project
HEP
1 other identifier
observational
488
3 countries
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 6, 2021
July 1, 2021
7.8 years
April 28, 2014
July 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response
up to 36 months
Study Arms (1)
focal epilepsy
observational study
Eligibility Criteria
Epilepsy/Neurology clinical centers
You may qualify if:
- Clinical seizure(s) and history consistent with focal epilepsy
- At least two confirmed spontaneous seizures, at least 24 hours apart, in the 12 months prior to enrollment
- Complete AED history prior to enrollment (with approximate dates and doses) is available (exception can be made for AEDs taken for \<1 week)
- Age ≥12 years and ≤60 years at time of seizure onset
- Age ≥12 years and ≤60 years at time of enrollment
- Treatment instituted not more than 4 months prior to enrollment
- One of the following:
- Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing)
- Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG
- Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG
- Focal lesion (non-progressive) on MRI with normal EEG (acceptable focal lesions include MTS, FCD, single cavernoma, and AVMs that are not of large size and lack significant amounts of hemosiderin)
You may not qualify if:
- Idiopathic or symptomatic generalized epilepsy
- Any epilepsy etiology that could produce significant gliosis or brain injury and would be likely to alter biomarkers. These include:
- Epilepsy with an etiology occurring in the previous two years that would produce significant CNS injury (e.g., traumatic brain injury that involves direct disruption of brain tissue, stroke, encephalitis)
- History of intracranial bleeding (e.g., subarachnoid, intraparenchymal)
- Identified genetic epilepsy syndrome
- Presence of moderate or greater developmental or cognitive delay prior to seizure onset (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be \> 70)
- History of chronic drug or alcohol abuse within the last 2 years
- IGE/focal epilepsy mixed syndromes
- Progressive neurological disorder (brain tumor, AD, PME, etc.)
- Major medical co-morbidities such as renal failure requiring dialysis, metastatic cancer, HIV, or significant liver or renal disease
- Autism Spectrum Disorder
- Seizures only during pregnancy
- History of previous or current significant psychiatric disorder that would interfere with conduct of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- The Epilepsy Study Consortiumcollaborator
Study Sites (30)
University of Alabama
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
North Shore-LIJ Health System
Great Neck, New York, United States
Albert Einstein College of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
New York University Langone Medical Center
New York, New York, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas
Houston, Texas, United States
Austin Hospital, University of Melbourne
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
Prince of Wales Hospital, University of New South Wales
Sydney, Australia
University of Western Ontario
London, Ontario, Canada
Related Publications (1)
Barnard SN, Chen Z, Holmes M, Kanner AM, Hegde M, Kuzniecky R, Lowenstein D, French JA; Human Epilepsy Project (1) Investigators. Treatment Response to Antiseizure Medications in People With Newly Diagnosed Focal Epilepsy. JAMA Neurol. 2025 Oct 1;82(10):1022-1030. doi: 10.1001/jamaneurol.2025.2949.
PMID: 40853673DERIVED
Related Links
Biospecimen
whole blood, plasma, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
April 30, 2014
Study Start
July 1, 2012
Primary Completion
March 31, 2020
Study Completion
July 1, 2021
Last Updated
July 6, 2021
Record last verified: 2021-07