Human Epilepsy Project 2: Resistant Focal Seizures Study (NCT03531008) | Clinical Trial Compass
CompletedNot Applicable
Human Epilepsy Project 2: Resistant Focal Seizures Study
United States157 participantsStarted 2018-05-07
Plain-language summary
The HEP2 study is designed to better understand the challenges of living with focal seizures that do not respond to medication, by following 205 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.
Who can participate
Age range16 Years – 65 Years
SexALL
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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 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
What they're measuring
1
Seizure freedom rates, seizure frequency and degree of disability
✕. 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