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The Human Epilepsy Project (HEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by New York University School of Medicine
Sponsor:
Collaborator:
The Epilepsy Study Consortium
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02126774
First received: April 28, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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
Focal Epilepsy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The Human Epilepsy Project

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, plasma, urine


Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126774

Contacts
Contact: Sabrina Cristofaro sabrina.cristofaro@nyumc.org

  Show 30 Study Locations
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
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02126774     History of Changes
Other Study ID Numbers: S12-02865
Study First Received: April 28, 2014
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014