A Study to Evaluate Newly-diagnosed Idiopathic Generalized Epilepsy

Overview

About this study

The purpose of this study is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with idiopathic generalized epilepsy (IGE).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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

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

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

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 1/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gregory Cascino, M.D.

Open for enrollment

Contact information:

Sherry Klingerman CCRP

(507) 284-0451

klingerman.sherry@mayo.edu

More information

Publications

Publications are currently not available