Ensayos clínicos

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.