The Human Epilepsy Project

Completed

• Conditions: Focal Epilepsy

• Registration Number: NCT02126774
• Lead Sponsor: NYU Langone Health

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Primary Completion: 2020-03-31
• Status Verified: 2021-07
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• 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:

  1. Normal MRI with inter-ictal EEG showing focal abnormality (focal sharp waves or focal slowing)
  2. Normal MRI and normal inter-ictal EEG, with clinical or electrographic seizure activity on ictal EEG
  3. Definitive clinical history of recurrent seizures consistent with focal epilepsy, adjudicated by central reviewers, if normal MRI and normal EEG
  4. 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)

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Exclusion Criteria

• 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:

  1. 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)
  2. 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response	up to 36 months

Trial Locations

Locations (30)

University of Miami; 🇺🇸 Miami, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Texas; 🇺🇸 Houston, Texas, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

North Shore-LIJ Health System; 🇺🇸 Great Neck, New York, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Prince of Wales Hospital, University of New South Wales; 🇦🇺 Sydney, Australia

Yale University; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Royal Melbourne Hospital; 🇦🇺 Melbourne, Australia

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Albert Einstein College of Medicine; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Austin Hospital, University of Melbourne; 🇦🇺 Melbourne, Australia

Mid-Atlantic Epilepsy and Sleep Center; 🇺🇸 Bethesda, Maryland, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Minnesota Epilepsy Group; 🇺🇸 Saint Paul, Minnesota, United States

Saint Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

New York University Langone Medical Center; 🇺🇸 New York, New York, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States