A Study to Identify Clinical Characteristics and Biomarkers of Disease Outcome, Progression, and Treatment Response in Participants with Treatment-resistant Focal Epilepsy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-001479
Sponsor Protocol Number: 18-001479
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. 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 ≥ 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 the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Gregory Cascino, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available