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NCT05374928 · ClinicalTrials.gov registry record
Human Epilepsy Project 3
A clinical trial of Idiopathic Generalized Epilepsy, sponsored by NYU Langone Health.
- Active
- Registry status
- 320
- Enrollment target
- 18
- Study locations
NCT05374928: Active study of Idiopathic Generalized Epilepsy, sponsored by NYU Langone Health.
NCT05374928 is a study of Idiopathic Generalized Epilepsy that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 320 participants. The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05374928, a study of Idiopathic Generalized Epilepsy, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- 320 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Conditions Studied
Study Locations (18)
New York
- NYU Langone Health - Comprehensive Epilepsy Center (CEC) - New York
- Mount Sinai Hospital - New York
- Northwell Health - New York
Maryland
- The Johns Hopkins Hospital - Baltimore
- Mid-Atlantic Epilepsy Sleep Center - Bethesda
Minnesota
- Mayo Clinic - Rochester
- Minnesota Epilepsy Group - Saint Paul
California
- University of California San Francisco (UCSF) - San Francisco
Connecticut
- Yale University - New Haven
District of Columbia
- Georgetown University - Washington D.C.
Florida
- University of Miami - Miami
Maine
- Maine Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2020-03-09 |
| Est. Completion | 2025-12 |
What the registry record for NCT05374928 still lists
NCT05374928 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Idiopathic Generalized Epilepsy appearing as the primary indexed condition, and to 0 interventions.
NCT05374928 lists 18 locations in 14 states (New York, Maryland, Minnesota).
Frequently Asked Questions
What is clinical trial NCT05374928 about?
NCT05374928 is a clinical study titled "Human Epilepsy Project 3". 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, inc...
What is the current status of trial NCT05374928?
This trial is currently active not recruiting. The enrollment target is 320 participants. The study started on 2020-03-09. Estimated completion is 2025-12.
What conditions does trial NCT05374928 study?
This clinical trial studies the following conditions: Idiopathic Generalized Epilepsy.
Who is sponsoring clinical trial NCT05374928?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05374928 being conducted?
This trial has 18 study locations across California, Connecticut, District of Columbia, Florida, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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