Focal EpilepsyHEPNCT02126774
The Human Epilepsy Project
An observational study of Focal Epilepsy, run by NYU Langone Health at 30 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Focal Epilepsy
- How many people
- 488 participants
- Where
- 30 sitesin 3 countries
- Study dates
- Jul 2012to 1 Jul 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Epilepsy/Neurology clinical centers
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States26 sites
University of Michigan
Ann Arbor, Michigan
Emory University
Atlanta, Georgia
Johns Hopkins School of Medicine
Baltimore, Maryland
University of Maryland Medical Center
Baltimore, Maryland
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland
University of Alabama
Birmingham, Alabama
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
Geisinger Medical Center
Danville, Pennsylvania
Children's Hospital Colorado
Denver, Colorado
North Shore-LIJ Health System
Great Neck, New York
University of Texas
Houston, Texas
Saint Barnabas Medical Center
Livingston, New Jersey
University of Miami
Miami, Florida
Vanderbilt University
Nashville, Tennessee
Yale University
New Haven, Connecticut
Albert Einstein College of Medicine
New York, New York
Columbia University Medical Center
New York, New York
New York University Langone Medical Center
New York, New York
University of Nebraska Medical Center
Omaha, Nebraska
Thomas Jefferson University
Philadelphia, Pennsylvania
Mayo Clinic
Rochester, Minnesota
Minnesota Epilepsy Group
Saint Paul, Minnesota
University of California San Francisco
San Francisco, California
Washington University
St Louis, Missouri
Australia3 sites
Austin Hospital, University of Melbourne
Melbourne
Royal Melbourne Hospital
Melbourne
Prince of Wales Hospital, University of New South Wales
Sydney
About this study
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.
Read the detailed description
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.
- Conditions
- Focal Epilepsy
- Keywords
- epilepsy, focal epilepsy
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| focal epilepsy | observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJul 2012
- Primary completion31 Mar 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Epilepsy Study Consortium
- Responsible party
- Sponsor
- Investigators
- Ruben Kuzniecky, MD, Principal investigator, New York University, Comprehensive Epilepsy CenterJacqueline French, MD, Principal investigator, New York University, Comprehensive Epilepsy CenterDaniel Lowenstein, MD, Principal investigator, University of California, San Francisco, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126774
- Sponsor's protocol ID
- 12-02865
- Acronym
- HEP
- Status last verified
- Jul 2021
- First submitted
- 28 Apr 2014
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40853673
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Human Epilepsy Project
- ClinicalTrials.gov ID
- NCT02126774
- Acronym / sponsor ID
- HEP / 12-02865
- Conditions
- Focal Epilepsy
- Keywords
- epilepsy, focal epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- The Epilepsy Study Consortium
- Study start
- Jul 2012 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| focal epilepsy | – | –observational study |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Epilepsy/Neurology clinical centers
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Derived from this study: PubMed 40853673Barnard 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.
- HEP websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Kuzniecky, MD principal investigator
New York University, Comprehensive Epilepsy Center
Jacqueline French, MD principal investigator
New York University, Comprehensive Epilepsy Center
Daniel Lowenstein, MD principal investigator
University of California, San Francisco, Department of Neurology
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy, run by NYU Langone Health at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.