Idiopathic Generalized EpilepsyHEP3NCT05374928
Human Epilepsy Project 3
An observational study of Idiopathic Generalized Epilepsy, run by NYU Langone Health at 18 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Idiopathic Generalized Epilepsy
- How many people
- 316 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 9 Mar 2020to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed IGE, as well as a cohort of subjects with established IGE.
Who may be able to join
- 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
Show all 42Show fewer
- 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
- 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
- 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 onset
- 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. This should include doses and date of initiation if possible, but minimum information would include name of drug, approximate duration of administration and reason for discontinuation, if applicable.
- No competing cause of epilepsy (e.g. traumatic brain injury)
- Treatment resistant IGE
- Initiation of treatment at least 2 years prior to enrollment
- Treatment resistance, as defined by failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination to achieve seizure freedom). ASMs taken at enrollment would count towards this minimum.
- Either or both of the following two:
- One GTCC per year over the last 2 years. ii. Any type of seizure at least every 3 months which can consist of either: disabling myoclonus or absence (in the opinion of the subject and investigator) or GTCC d. Such seizures were not primarily due to significant illness (e.g, URI is not significant unless temperature >101oF (38.3oC), nonadherence to antiseizure medications or >2 alcoholic beverages within 48 hrs of seizure e. Ongoing therapy with > 1 antiseizure medication
Who cannot join
- 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
Show all 32Show fewer
- 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
- Focal epilepsy
- Paroxysmal nonepileptic seizures
- 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 3: Longstanding IGE, Treatment Resistant
- Focal epilepsy
- Paroxysmal nonepileptic seizures
- 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
- History of/suspicion of provoked seizures accounting for 25% or more of seizures over the prior 2 years (eg alcohol, non-adherence, significant sleep deprivation).
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mid-Atlantic Epilepsy Sleep Center
Bethesda, Maryland, 20817
St. Barnabas Medical Center
Livingston, New Jersey, 07039
University of Miami
Miami, Florida, 33146
Yale University
New Haven, Connecticut, 06520
NYU Langone Health - Comprehensive Epilepsy Center (CEC)
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Northwell Health
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Mayo Clinic
Rochester, Minnesota, 55905
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55113
University of Utah Hospital
Salt Lake City, Utah, 84132
University of Texas Health Science Center
San Antonio, Texas, 77030
University of California San Francisco (UCSF)
San Francisco, California, 94143
Washington University
St Louis, Missouri, 63130
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Human Epilepsy Project 3: Newly Diagnosed Idiopathic Generalized Epilepsy
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
- Medical subject headings
- Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Newly Diagnosed Idiopathic Generalized Epilepsy (IGE) | Cohort 1 will have IGE that was diagnosed within the prior year. We will follow these participants for a minimum of two years. | |
| Cohort 2: Longstanding Treatment Responsive | Cohort 2 will consist of subjects with established IGE who have been responsive to treatment. | |
| Cohort 3: Longstanding IGE, Treatment Resistant | Cohort 3 will consist of patients with established treatment-resistant IGE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Individual Seizures
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Measured: Baseline
Number of Cluster Seizures
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Measured: Baseline
Number of episodes of non-adherence
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Measured: Baseline
Average daily steps
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Measured: Baseline
Average distance walked
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Measured: Baseline
Average heart rate
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Measured: Baseline
Average daily sleep duration
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study. Using the Embleema Patient Web App, participants will be able to consult their activity and sleep data in interactive graphs.
Measured: Baseline
Average daily wake duration
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study. Using the Embleema Patient Web App, participants will be able to consult their activity and sleep data in interactive graphs.
Measured: Baseline
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Measured: Baseline, Month 12
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Measured: Baseline, Month 24
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Measured: Month 12, Month 24
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Measured: Baseline, Month 12
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Measured: Baseline, Month 24
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Measured: Month 12, Month 24
Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Measured: Baseline
Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Measured: Month 12
Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Measured: Month 24
Cogstate Neuropsychological Assessment Score
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Measured: Baseline
Cogstate Neuropsychological Assessment Score
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Measured: Month 12
Cogstate Neuropsychological Assessment Score
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Measured: Month 24
Wide Range Achievement Test (WRAT-4) Score
WRAT4 is an academic skills assessment which measures reading skills, math skills, spelling, and comprehension. Only the Word Reading portion of the assessment will be administered. The total raw score range is from 0-70, with a normalized score range of 55-145. The higher the score, the more advanced the participant's reading comprehension skills for their age range.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start9 Mar 2020
- Primary completion31 Dec 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Generalized EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374928
- Sponsor's protocol ID
- 19-01030
- Acronym
- HEP3
- Status last verified
- Jun 2026
- First submitted
- 11 May 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Epilepsy Project 3: Newly Diagnosed Idiopathic Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT05374928
- Acronym / sponsor ID
- HEP3 / 19-01030
- Conditions
- Idiopathic Generalized Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Newly Diagnosed Idiopathic Generalized Epilepsy (IGE) | – | –Cohort 1 will have IGE that was diagnosed within the prior year. We will follow these participants for a minimum of two years. |
| Cohort 2: Longstanding Treatment Responsive | – | –Cohort 2 will consist of subjects with established IGE who have been responsive to treatment. |
| Cohort 3: Longstanding IGE, Treatment Resistant | – | –Cohort 3 will consist of patients with established treatment-resistant IGE. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed IGE, as well as a cohort of subjects with established IGE.
Key inclusion criteria (42 listed)
- 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:
Key exclusion criteria (32 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Individual Seizures
Time frame: Baseline
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Number of Cluster Seizures
Time frame: Baseline
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Number of episodes of non-adherence
Time frame: Baseline
Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
Average daily steps
Time frame: Baseline
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Average distance walked
Time frame: Baseline
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Average heart rate
Time frame: Baseline
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study.
Average daily sleep duration
Time frame: Baseline
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study. Using the Embleema Patient Web App, participants will be able to consult their activity and sleep data in interactive graphs.
Average daily wake duration
Time frame: Baseline
Participants will be provided a Fitbit Inspire HR watch and will be trained to open an account on fitbit.com and synchronize their Fitbit watch data into their Fitbit cloud account. Daily steps is synchronized and collected for this study. Using the Embleema Patient Web App, participants will be able to consult their activity and sleep data in interactive graphs.
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
Time frame: Baseline, Month 12
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
Time frame: Baseline, Month 24
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
Time frame: Month 12, Month 24
QOLIE-10 assesses the patient's quality of life. There are 11 total items. The total score range is 10-51; with higher scores indicating greater impairment. The total score is the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score.
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
Time frame: Baseline, Month 12
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
Time frame: Baseline, Month 24
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Change in General Anxiety Disorder-7 Screener (GAD-7) Score
Time frame: Month 12, Month 24
This will only be reported for adults. GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Month 12
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Month 24
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) - 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention
Cogstate Neuropsychological Assessment Score
Time frame: Baseline
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Cogstate Neuropsychological Assessment Score
Time frame: Month 12
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Cogstate Neuropsychological Assessment Score
Time frame: Month 24
The Cogstate is a battery of online computerized tests that assesses functions such as attention, memory, and processing speed. Scores are normalized to the range of 0-100th percentile based on speed of test completion and task accuracy. A higher percentile score indicates higher levels of cognitive functioning within the tested domain as compared to controls.
Wide Range Achievement Test (WRAT-4) Score
Time frame: Baseline
WRAT4 is an academic skills assessment which measures reading skills, math skills, spelling, and comprehension. Only the Word Reading portion of the assessment will be administered. The total raw score range is from 0-70, with a normalized score range of 55-145. The higher the score, the more advanced the participant's reading comprehension skills for their age range.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Idiopathic Generalized Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
RecruitingObservational study
Idiopathic Generalized Epilepsy Syndromes
Epilepsy, Epilepsy, Idiopathic Generalized
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Focal Onset Seizure, Primary Generalized Epilepsy
RecruitingObservational study
Idiopathic Generalized Epilepsy Cognitive and Emotional Profile
Epilepsy, Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Generalized Epilepsy, run by NYU Langone Health at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Individual Seizures (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.