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The Human Epilepsy Project (HEP)

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ClinicalTrials.gov Identifier: NCT02126774
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
The Epilepsy Study Consortium
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease
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 Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Human Epilepsy Project
Study Start Date : July 2012
Actual Primary Completion Date : March 6, 2018
Estimated Study Completion Date : July 2020


Group/Cohort
focal epilepsy
observational study



Primary Outcome Measures :
  1. Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response [ Time Frame: up to 36 months ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Epilepsy/Neurology clinical centers
Criteria

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)

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

Information from the National Library of Medicine

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


  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, California
University of California San Francisco
San Francisco, California, United States
United States, Colorado
Children's Hospital Colorado
Denver, Colorado, United States
United States, Connecticut
Yale University
New Haven, Connecticut, United States
United States, Florida
University of Miami
Miami, Florida, United States
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Maryland
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
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
United States, Missouri
Washington University
Saint Louis, Missouri, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States
United States, New York
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
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
United States, Texas
University of Texas
Houston, Texas, United States
Australia
Austin Hospital, University of Melbourne
Melbourne, Australia
Royal Melbourne Hospital
Melbourne, Australia
Prince of Wales Hospital, University of New South Wales
Sydney, Australia
Canada, Ontario
University of Western Ontario
London, Ontario, Canada
Sponsors and Collaborators
New York University School of Medicine
The Epilepsy Study Consortium
Investigators
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

Additional Information:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02126774     History of Changes
Other Study ID Numbers: 12-02865
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by New York University School of Medicine:
epilepsy
focal epilepsy

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases