Human Epilepsy Project 3

Completed

Conditions studied: Idiopathic Generalized Epilepsy

In brief

By carrying a careful, large-scale and ambitious prospective study of a cohort of participants with generalized epilepsy, the study team hopes to clarify the likelihood of response and remission in this type of epilepsy, and try to explore the underlying biological drivers of treatment response, including novel realms of exploration such as impact of the microbiome, and genetics. The identification of biomarkers that predict the likelihood of disease response would allow epilepsy patients to make more informed decisions about the factors affecting their quality of life, including plans for driving, relationships, pregnancy, schooling, work, and play. In addition to its impact on clinical care, the data and specimens collected in HEP3, including sequential electrophysiology, biochemical profiles and neuroimaging and banked DNA for future genomics studies, have the potential to provide new insights into the biological basis of IGE, thereby advancing the discovery of effective treatments and cures. By enrolling both newly diagnosed subjects (prognosis unknown) as well as subjects with established IGE who are already determined to be treatment resistant or treatment responsive, the study team can immediately test potential biomarkers in a confirmation cohort, which will accelerate identification of predictive biomarkers.

Key facts

Study ID: NCT05374928
Run by: NYU Langone Health
People needed: 316
Starts: 2020-03-09
Expected to finish: 2026-06-01
Last updated by the study team: 2026-06-22

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥13 years at time of enrollment
Age ≥8 years at time of seizure onset
Clinical seizure(s) and history consistent with IGE. The only permitted seizure types are absence, myoclonus or generalized tonic-clonic convulsions
Occurrence of at least 1 seizure of any type in the 6 months prior to treatment
Patients must have one of the following:
GTCSs alone accompanied by generalized spike-wave consistent with IGE per adjudication review
GTCSs with a history of absence and/or myoclonus, accompanied by generalized spike-wave consistent with IGE per adjudication review
GTCSs associated with a history of absence and/or myoclonus, not accompanied by generalized spike-wave consistent with IGE per adjudication review
A clear history of absence and/or myoclonus, accompanied by generalized spike-wave consistent with IGE per adjudication review
Availability of a complete medication history since initiation of treatment, including doses and date of initiation
No competing cause of epilepsy (e.g. traumatic brain injury)
AED treatment (for seizures) instituted not more than 12 months before enrollment

You may not qualify if…

Focal epilepsy
Generalized/focal epilepsy mixed syndromes
Progressive neurological disorder (brain tumor, Alzheimer's disease, progressive myoclonic epilepsy, etc.)
Epileptic or developmental encephalopathy
Major medical co-morbidities (e.g. renal failure requiring dialysis, metastatic cancer, HIV, or significant liver or renal disease)
Autism Spectrum Disorder
History of chronic drug or alcohol abuse (misuse or excessive use that interferes with activities of daily living) within the last 2 years
Seizures only during pregnancy
History of previous or current significant psychiatric disorder that would interfere with study requirements
Cohort 2: Longstanding Treatment Responsive
Inclusion Criteria:
Age ≥13 years at time of enrollment
Age ≥8 years at time of seizure onset
Clinical seizure(s) and history consistent with IGE. The only permitted seizure types are absence, myoclonus or generalized tonic-clonic convulsions
Patients must have had one of the following:
GTCSs alone accompanied by generalized spike-wave consistent with IGE per adjudication review
GTCSs with a history of absence and/or myoclonus, accompanied by generalized spike-wave consistent with IGE per adjudication review
GTCSs associated with a history of absence and/or myoclonus, not accompanied by generalized spike-wave consistent with IGE per adjudication review
A clear history of absence and/or myoclonus, accompanied by generalized spike-wave consistent with IGE per adjudication review
Availability of a complete medication history since initiation of treatment, including doses and date of initiation
No competing cause of epilepsy (e.g. traumatic brain injury)
Two years of well-controlled seizures.
No convulsive seizures in the last two years
Myoclonic or absence seizures must be rare (<2 per year) and non-disabling
Ongoing therapy with > 1 antiseizure medication

Where it is running

University of California San Francisco (UCSF) — San Francisco, California, United States
Yale University — New Haven, Connecticut, United States
Georgetown University — Washington D.C., District of Columbia, United States
University of Miami — Miami, Florida, United States
Maine Medical Center — Portland, Maine, United States
The Johns Hopkins Hospital — Baltimore, Maryland, United States
Mid-Atlantic Epilepsy Sleep Center — Bethesda, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
Minnesota Epilepsy Group — Saint Paul, Minnesota, United States
Washington University — St Louis, Missouri, United States
St. Barnabas Medical Center — Livingston, New Jersey, United States
NYU Langone Health - Comprehensive Epilepsy Center (CEC) — New York, New York, United States
Mount Sinai Hospital — New York, New York, United States
Northwell Health — New York, New York, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Texas Health Science Center — San Antonio, Texas, United States
University of Utah Hospital — Salt Lake City, Utah, United States
Monash University — Melbourne, Clayton VIC, Australia

Full record on ClinicalTrials.gov

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