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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02126774
Other study ID # 12-02865
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2012
Est. completion date July 1, 2021

Study information

Verified date July 2021
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 488
Est. completion date July 1, 2021
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Austin Hospital, University of Melbourne Melbourne
Australia Royal Melbourne Hospital Melbourne
Australia Prince of Wales Hospital, University of New South Wales Sydney
Canada University of Western Ontario London Ontario
United States University of Michigan Ann Arbor Michigan
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 University of Alabama Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Geisinger Medical Center Danville Pennsylvania
United States Children's Hospital Colorado Denver Colorado
United States North Shore-LIJ Health System Great Neck New York
United States University of Texas Houston Texas
United States Saint Barnabas Medical Center Livingston New Jersey
United States University of Miami Miami Florida
United States Vanderbilt University Nashville Tennessee
United States Yale University New Haven Connecticut
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 University of Nebraska Medical Center Omaha Nebraska
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Washington University Saint Louis Missouri
United States Minnesota Epilepsy Group Saint Paul Minnesota
United States University of California San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health The Epilepsy Study Consortium

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response up to 36 months
See also
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Recruiting NCT05198882 - Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy Phase 1
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