A Study to Identify Clinical Characteristics and Biomarkers of Disease Outcome, Progression, and Treatment Response in Participants with Treatment-resistant Focal 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 treatment-resistant focal epilepsy.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Age ≥ 16 years and ≤ 65 years at time of enrollment.
  • Diagnosed with focal epilepsy with prior vEEG confirmation; if no VEEG confirmation, but in the opinion of the investigator the seizures are definite, the case can be reviewed and adjudicated by the consortium.
  • Failure of adequate trials of 4 AEDs, with at least 2 due to failure of seizure control, including current AEDs.
  • Have a seizure frequency of ≥ 2 focal seizures/month, including auras, and at least 1 observable seizure/month, that are countable by the subject and/or caregiver for the 3 months prior to enrollment.
  • Able to keep a daily seizure diary, either independently or with assistance from a caregiver.
  • Able to retrospectively report number of seizures/month for 3 months prior to enrollment.
  • Receiving ≥ 1 AED for treatment of seizures.

Exclusion Criteria:

  • Patient has a diagnosis of idiopathic (“primary”) generalized epilepsy (e.g., juvenile myoclonic epilepsy, absence epilepsy) or mixed focal and generalized (e.g., Lennox-Gastaut syndrome) or non-epileptic seizures within the last 12 months prior to study entry.
  • Progressive medical or neurological disorder (brain tumor, AD, PME, etc.).
  • Proven autoimmune etiology.
  • Planning pregnancy in the next 12 months.
  • Has completed a pre-surgical evaluation and intends to pursue surgery in the near term.
  • Resective surgery and/or RNS/VNS in place less than 12 months prior to enrollment.
  • Presence of moderate or greater developmental or cognitive delay (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be ≥ 70).
  • History of chronic drug or alcohol abuse (misuse or excessive use that interferes with activities of daily living) within the last 2 years.
  • Medical, psychiatric or psychosocial condition that would be expected to interfere with the conduct of the study.
  • Enrolled in any interventional study that required a blinded portion or involves a non FDA approved drug or device.

     

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

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