Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria - Cohort 1: Newly Diagnosed IGE:
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.
9. Diagnosis of IGE made not more than 12 months before enrollment.
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.
10. Current pregnancy.
Inclusion Criteria - Cohort 2: Longstanding Treatment Responsive:
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:
- 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.
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.
- 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.
Exclusion Criteria:
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.
12. Current pregnancy.
Inclusion Criteria - Cohort 3: Longstanding IGE, Treatment Resistant:
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:
- 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. 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.
7. No competing cause of epilepsy (e.g., traumatic brain injury).
8. 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:
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
iii 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.
Exclusion Criteria:
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).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply..
Eligibility last updated 12/28/23. Questions regarding updates should be directed to the study team contact.