- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126774
The Human Epilepsy Project (HEP)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Melbourne, Australia
- Royal Melbourne Hospital
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Melbourne, Australia
- Austin Hospital, University of Melbourne
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Sydney, Australia
- Prince of Wales Hospital, University of New South Wales
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Ontario
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London, Ontario, Canada
- University of Western Ontario
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Alabama
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Birmingham, Alabama, United States
- University Of Alabama
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California
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San Francisco, California, United States
- University of California San Francisco
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Colorado
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Denver, Colorado, United States
- Children's Hospital Colorado
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Connecticut
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New Haven, Connecticut, United States
- Yale University
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Florida
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Miami, Florida, United States
- University of Miami
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Georgia
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Atlanta, Georgia, United States
- Emory University
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Maryland
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Baltimore, Maryland, United States
- University of Maryland Medical Center
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Baltimore, Maryland, United States
- Johns Hopkins School of Medicine
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Bethesda, Maryland, United States
- Mid-Atlantic Epilepsy and Sleep Center
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Massachusetts
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Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan
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Minnesota
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Rochester, Minnesota, United States
- Mayo Clinic
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Saint Paul, Minnesota, United States
- Minnesota Epilepsy Group
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Missouri
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Saint Louis, Missouri, United States
- Washington University
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Nebraska
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Omaha, Nebraska, United States
- University of Nebraska Medical Center
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New Jersey
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Livingston, New Jersey, United States
- Saint Barnabas Medical Center
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New York
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Great Neck, New York, United States
- North Shore-LIJ Health System
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New York, New York, United States
- Columbia University Medical Center
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New York, New York, United States
- New York University Langone Medical Center
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New York, New York, United States
- Albert Einstein College of Medicine
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Pennsylvania
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Danville, Pennsylvania, United States
- Geisinger Medical Center
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Philadelphia, Pennsylvania, United States
- Thomas Jefferson University
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South Carolina
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Charleston, South Carolina, United States
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, United States
- Vanderbilt University
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Texas
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Houston, Texas, United States
- University of Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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)
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:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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focal epilepsy
observational study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response
Time Frame: up to 36 months
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up to 36 months
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Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-02865
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Focal Epilepsy
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Assistance Publique - Hôpitaux de ParisMedtronicRecruitingEpilepsy | Focal Epilepsy | Drug Resistant | Drug-resistant Focal Epilepsy | Epilepsies, FocalFrance
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Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
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Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
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Peking Union Medical College HospitalGuidon Pharmaceutics Ltd.RecruitingRefractory Focal EpilepsyChina
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Fondation Ophtalmologique Adolphe de RothschildRecruitingDrug Resistant Epilepsy | Pediatrics | Epilepsies, FocalFrance
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BiocodexRecruitingPharmacoresistant Focal EpilepsiesFrance
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UCB Biopharma SRLTerminatedAn Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal EpilepsyHighly Drug-resistant Focal EpilepsyBelgium, Bulgaria, Germany, Hungary, Netherlands, Spain
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UCB Biopharma S.P.R.L.PRA Health SciencesCompletedHighly Drug-resistant Focal EpilepsyBelgium, Bulgaria, Germany, Hungary, Netherlands, Spain
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BiogenCompletedEpilepsy, Focal Seizures, Partial SeizuresUnited States
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UCB Pharma GmbHCompletedFocal Epilepsy With and Without Secondary GeneralizationGermany, Austria