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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05374928
Registration number
NCT05374928
Ethics application status
Date submitted
11/05/2022
Date registered
16/05/2022
Date last updated
25/01/2024
Titles & IDs
Public title
Human Epilepsy Project 3
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Scientific title
Human Epilepsy Project 3: Newly Diagnosed Idiopathic Generalized Epilepsy
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Secondary ID [1]
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19-01030
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Universal Trial Number (UTN)
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Trial acronym
HEP3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Generalized Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Individual Seizures
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Assessment method [1]
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Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Number of Cluster Seizures
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Assessment method [2]
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Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Number of episodes of non-adherence
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Assessment method [3]
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Self-reported via the Seer Seizure Diary App (https://app.seermedical.com)
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Timepoint [3]
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Baseline
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Primary outcome [4]
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Average daily steps
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Primary outcome [5]
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Average distance walked
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline
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Primary outcome [6]
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Average heart rate
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Average daily sleep duration
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Primary outcome [8]
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Average daily wake duration
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline
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Primary outcome [9]
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Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Month 12
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Primary outcome [10]
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Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Month 24
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Primary outcome [11]
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Change in Quality of Life in Epilepsy Inventory-10 (QOLIE-10) Score
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Assessment method [11]
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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.
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Timepoint [11]
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Month 12, Month 24
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Primary outcome [12]
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Change in General Anxiety Disorder-7 Screener (GAD-7) Score
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Month 12
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Primary outcome [13]
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Change in General Anxiety Disorder-7 Screener (GAD-7) Score
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Month 24
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Primary outcome [14]
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Change in General Anxiety Disorder-7 Screener (GAD-7) Score
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Assessment method [14]
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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.
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Timepoint [14]
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Month 12, Month 24
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Primary outcome [15]
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Columbia Suicide Severity Rating Scale (C-SSRS) Score
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Assessment method [15]
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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
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Timepoint [15]
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Baseline
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Primary outcome [16]
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Columbia Suicide Severity Rating Scale (C-SSRS) Score
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Assessment method [16]
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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
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Timepoint [16]
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Month 12
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Primary outcome [17]
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Columbia Suicide Severity Rating Scale (C-SSRS) Score
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Assessment method [17]
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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
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Timepoint [17]
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Month 24
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Primary outcome [18]
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Cogstate Neuropsychological Assessment Score
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline
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Primary outcome [19]
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Cogstate Neuropsychological Assessment Score
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Assessment method [19]
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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.
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Timepoint [19]
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Month 12
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Primary outcome [20]
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Cogstate Neuropsychological Assessment Score
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Assessment method [20]
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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.
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Timepoint [20]
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Month 24
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Primary outcome [21]
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Wide Range Achievement Test (WRAT-4) Score
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline
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Eligibility
Key inclusion criteria
Cohort 1: Newly Diagnosed IGE
Inclusion criteria:
1. Age =13 years at time of enrollment
2. Age =8 years at time of seizure onset
3. Clinical seizure(s) and history consistent with IGE. The only permitted seizure types
are absence, myoclonus or generalized tonic-clonic convulsions
4. Occurrence of at least 1 seizure of any type in the 6 months prior to treatment
5. 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
6. Availability of a complete medication history since initiation of treatment, including
doses and date of initiation
7. No competing cause of epilepsy (e.g. traumatic brain injury)
8. AED treatment (for seizures) instituted not more than 12 months before enrollment
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Minimum age
13
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Focal epilepsy
2. Generalized/focal epilepsy mixed syndromes
3. Progressive neurological disorder (brain tumor, Alzheimer's disease, progressive
myoclonic epilepsy, etc.)
4. Epileptic or developmental encephalopathy
5. Major medical co-morbidities (e.g. renal failure requiring dialysis, metastatic
cancer, HIV, or significant liver or renal disease)
6. Autism Spectrum Disorder
7. History of chronic drug or alcohol abuse (misuse or excessive use that interferes with
activities of daily living) within the last 2 years
8. Seizures only during pregnancy
9. History of previous or current significant psychiatric disorder that would interfere
with study requirements
Cohort 2: Longstanding Treatment Responsive
Inclusion Criteria:
1. Age =13 years at time of enrollment
2. Age =8 years at time of seizure onset
3. Clinical seizure(s) and history consistent with IGE. The only permitted seizure types
are absence, myoclonus or generalized tonic-clonic convulsions
4. Patients must have had one of the following:
1. GTCSs alone accompanied by generalized spike-wave consistent with IGE per
adjudication review
2. GTCSs with a history of absence and/or myoclonus, accompanied by generalized
spike-wave consistent with IGE per adjudication review
3. GTCSs associated with a history of absence and/or myoclonus, not accompanied by
generalized spike-wave consistent with IGE per adjudication review
4. A clear history of absence and/or myoclonus, accompanied by generalized
spike-wave consistent with IGE per adjudication review
5. Availability of a complete medication history since initiation of treatment, including
doses and date of initiation
6. No competing cause of epilepsy (e.g. traumatic brain injury)
7. Two years of well-controlled seizures.
1. No convulsive seizures in the last two years
2. Myoclonic or absence seizures must be rare (<2 per year) and non-disabling
3. Ongoing therapy with > 1 antiseizure medication
1. Focal epilepsy
2. Paroxysmal nonepileptic seizures
3. Generalized/focal epilepsy mixed syndromes
4. Progressive neurological disorder (brain tumor, Alzheimer's disease, progressive
myoclonic epilepsy, etc.)
5. Epileptic or developmental encephalopathy
6. Major medical co-morbidities (e.g. renal failure requiring dialysis, metastatic
cancer, HIV, or significant liver or renal disease)
7. Autism Spectrum Disorder
8. History of chronic drug or alcohol abuse (misuse or excessive use that interferes with
activities of daily living) within the last 2 years
9. Seizures only during pregnancy
10. History of previous or current significant psychiatric disorder that would interfere
with study requirements
Cohort 3: Longstanding IGE, Treatment Resistant
Inclusion Criteria:
1. Age =13 years at time of enrollment
2. Age =8 years at time of seizure onset
3. Clinical seizure(s) and history consistent with IGE. The only permitted seizure types
are absence, myoclonus or generalized tonic-clonic convulsions
4. Occurrence of at least 1 seizure of any type in the 6 months prior to treatment onset
5. Patients must have had one of the following:
1. GTCSs alone accompanied by generalized spike-wave consistent with IGE per
adjudication review
2. GTCSs with a history of absence and/or myoclonus, accompanied by generalized
spike-wave consistent with IGE per adjudication review
3. GTCSs associated with a history of absence and/or myoclonus, not accompanied by
generalized spike-wave consistent with IGE per adjudication review
4. A clear history of absence and/or myoclonus, accompanied by generalized
spike-wave consistent with IGE per adjudication review
6. 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.
7. No competing cause of epilepsy (e.g. traumatic brain injury)
8. Treatment resistant IGE
1. Initiation of treatment at least 2 years prior to enrollment
2. 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.
3. Either or both of the following two:
i. 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
1. Focal epilepsy
2. Paroxysmal nonepileptic seizures
3. Generalized/focal epilepsy mixed syndromes
4. Progressive neurological disorder (brain tumor, Alzheimer's disease, progressive
myoclonic epilepsy, etc.)
5. Epileptic or developmental encephalopathy
6. Major medical co-morbidities (e.g. renal failure requiring dialysis, metastatic
cancer, HIV, or significant liver or renal disease)
7. Autism Spectrum Disorder
8. History of chronic drug or alcohol abuse (misuse or excessive use that interferes with
activities of daily living) within the last 2 years
9. Seizures only during pregnancy
10. History of previous or current significant psychiatric disorder that would interfere
with study requirements
11. 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).
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
Clayton VI
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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3800 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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District of Columbia
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Maine
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Country [6]
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United States of America
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State/province [6]
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Maryland
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Country [7]
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United States of America
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State/province [7]
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Minnesota
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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State/province [9]
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New Jersey
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Country [10]
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United States of America
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State/province [10]
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New York
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Country [11]
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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United States of America
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State/province [13]
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Utah
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Funding & Sponsors
Primary sponsor type
Other
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Name
NYU Langone Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05374928
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jacqueline French, MD
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Address
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Country
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Phone
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646-558-0839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05374928
Download to PDF