The Human Epilepsy Project

Focal Epilepsy Clinical Trial

— HEP  

Official title:

The Human Epilepsy Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126774
• Other study ID #: 12-02865
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

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

External Links

•   HEP website