Human Epilepsy Project 2: Resistant Focal Seizures Study
- Study HIC#:2000022824
- Last Updated:07/15/2021
The Human Epilepsy Project2 (HEP2) is a prospective, observational study whose primary goal is to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with treatment-resistant focal epilepsy. The data to be collected on these participants include high-resolution clinical phenotyping (including comorbidities) and treatment response, neuroimaging reports, electrophysiology reports, and biosamples for genomics, proteomics, metabolomic and transcriptome analyses. A major objective of the project is to create an open data repository of clinical information and biologic samples for future studies.
- Age16 years - 65 years
- Start Date11/06/2018
- End Date07/31/2020
Trial Purpose and Description
The Human Epilepsy Project 2: Resistant Focal Seizures Study (HEP2 for short) is a research project to better understand what happens over time in people with focal seizures that don’t respond to current treatment.
This is a two year, observational study. The study will not affect the treatment of your seizures in any way. We estimate that approximately 200 people will take part in this study.
If you decide to take part in this study, you will have 2-3 in person study visits, which will take place over the next 2 years. We will collect blood samples from you at the beginning and the end of the study. With these samples, we will try to find markers that help us better understand why you are having seizures and to determine which of these markers predict what happens with your condition in the future. We will also ask you to complete some online questionnaires, have once-a-month check in calls with the study coordinator, and to keep a daily seizure diary.
There is no cost for you to participate in this study. You will receive compensation at each annual visit. Although you may not benefit directly from taking part in this study, you will contribute to the knowledge we gain from participants in this study that could help individuals with epilepsy in the future.
- Age ≥ 16 years and ≤ 65 years at time of enrollment
- Diagnosed with Focal Epilepsy
- Must have tried 4 or more anti-epileptic drugs with no success (including current AEDs)
- Must 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
- Able to keep a daily seizure diary, either independently or with assistance from a caregiver
- Currently receiving ≥ 1 AED for treatment of seizures
- Progressive medical or neurological disorder
- Planning pregnancy in next 12 months
- Has completed pre-surgical evaluation and intends to pursue surgery in near term
- Resective surgery and/or RNS/BNS in place less than 12 months prior to enrollment
- Moderate or greater developmental or cognitive delay
- History of chronic drug or alcohol abuse
- Enrolled in an interventional study that required a blinded portion or involves a non-FDA approved drug or device
- Any other medical, psychological, or social condition that may interfere with participation in the study