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 newly-diagnosed 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.

Inclusion Criteria:

  • 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 last 6 months.
  • Patients must have one of the following:
    • GTCSs alone accompanied by generalized spike/wave of > 3 Hz on EEG;
    • GTCSs with a history of absence and/or myoclonus, accompanied by generalized spike/wave of > 3 Hz on EEG;
    • GTCSs associated with a history of absence and/or myoclonus, not accompanied by generalized spike/wave of > 3 Hz on EEG and adjudicated for enrollment;
    • A clear history of absence and/or myoclonus, accompanied by generalized spike/wave of > 3 Hz on EEG. 
  • 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 6 months before enrollment.

Exclusion Criteria:

  • 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.
  • 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.

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20514653

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