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Trial record 73 of 146 for:    epilepsy AND Bethesda

The Human Epilepsy Project (HEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126774
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
The Epilepsy Study Consortium
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date April 28, 2014
First Posted Date April 30, 2014
Last Update Posted Date August 12, 2019
Study Start Date July 2012
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2014)
Presence of Biomarker(s) Predictive of Anti-epileptic Drug Treatment Response [ Time Frame: up to 36 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02126774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Human Epilepsy Project
Official Title The Human Epilepsy Project
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.
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
whole blood, plasma, urine
Sampling Method Non-Probability Sample
Study Population Epilepsy/Neurology clinical centers
Condition Focal Epilepsy
Intervention Not Provided
Study Groups/Cohorts focal epilepsy
observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 29, 2018)
500
Original Estimated Enrollment
 (submitted: April 28, 2014)
600
Estimated Study Completion Date July 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02126774
Other Study ID Numbers 12-02865
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party NYU Langone Health
Study Sponsor NYU Langone Health
Collaborators 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
PRS Account NYU Langone Health
Verification Date August 2019