May 21, 2018

Clinical Trial: Human Epilepsy Project 2 – Resistant Focal Seizures Study

Brief Summary: The Human Epilepsy Project 2 (HEP2) study is designed to better understand the challenges of living with focal seizures that do not respond to medication, by following 200 people with medication-resistant focal epilepsy over two years to measure changes in health status, healthcare costs, quality of life, and biomarkers of epilepsy severity and treatment response.

Primary Outcome Measures: Seizure freedom rates, seizure frequency and degree of disability (Time Frame: 24 Months)

Secondary Outcome Measures: Medication changes (Time Frame: 24 months), Healthcare utilization (Time Frame: 24 months)

Study start date: May 7, 2018
Estimated study completion date: September 2020

Eligibility Criteria

Ages Eligible for Study: 16 Years to 65 Years (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

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 ? 4 focal seizures/month, including auras, and at least 2 observable seizures/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
  • Intent to pursue surgical resection intervention in the next two years
  • 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

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