NCT05374928

Human Epilepsy Project 3

Human Epilepsy Project 3: Newly Diagnosed Idiopathic Generalized Epilepsy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Idiopathic Generalized Epilepsy

Timeline

• Start date: 2020-03-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-05-16
• Last updated: 2025-07-04

Locations

18 sites across 2 countries: United States, Australia