Human Epilepsy Project 2: Resistant Focal Seizures Study

Completed

• Conditions: Brain Diseases; Epilepsy; Central Nervous System Diseases; Nervous System Diseases; Biomarkers

• Registration Number: NCT03531008
• Lead Sponsor: Epilepsy Foundation of America

Brief 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.

Detailed Description

The Epilepsy Foundation is launching a partnership, called the Human Epilepsy Project, in collaboration with the Epilepsy Study Consortium. This study (which is called HEP2 for short) is designed to better understand the challenges of living with focal seizures that do not respond to medication. The HEP2 study will follow 200 people with medication-resistant focal epilepsy (with seizures that occur at least 2 times per month) over two years to measure changes in their seizure frequency, treatments used, adverse events experienced, presence of co-morbidities like depression and anxiety, healthcare costs, and quality of life. Blood samples will also be collected in order to look for biomarkers of epilepsy severity and treatment response.

Participants can join the HEP2 study at any one of nine recruiting study centers. These study centers were selected because they are epilepsy centers with track records of conducting high-quality research in epilepsy and efficiently recruiting participants into studies. The designated sites for the HEP2 study are located in New York, California, Minnesota, Connecticut, Pennsylvania, and Tennessee. A participant may enroll in the HEP2 study but continue to receive their standard epilepsy care with their current physician, as long as the participant is willing to share his or her medical records, and travel to the study center for two or three in person visits at the beginning of the study, after the first year, and a final visit after the second year.

Study Timeline

• Study First Submitted: 2018-04-25
• Study Start: 2018-05-07
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2022-07-30
• Study Completion: 2022-09-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

1. Age ≥ 16 years and ≤ 65 years at time of enrollment
2. 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
3. Failure of adequate trials of 4 AEDs, with at least 2 due to failure of seizure control, including current AEDs
4. 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
5. Able to keep a daily seizure diary, either independently or with assistance from a caregiver
6. Able to retrospectively report number of seizures/month for 3 months prior to enrollment
7. Receiving ≥ 1 AED for treatment of seizures

Exclusion Criteria

1. 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
2. Progressive medical or neurological disorder (brain tumor, AD, PME, etc.)
3. Proven autoimmune etiology
4. Planning pregnancy in the next 12 months
5. Has completed a pre-surgical evaluation and intends to pursue surgery in the near term
6. Resective surgery and/or RNS/VNS in place less than 12 months prior to enrollment
7. 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)
8. History of chronic drug or alcohol abuse (misuse or excessive use that interferes with activities of daily living) within the last 2 years
9. Medical, psychiatric or psychosocial condition that would be expected to interfere with the conduct of the study
10. Enrolled in any interventional study that required a blinded portion or involves a non-FDA approved drug or device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure freedom rates, seizure frequency and degree of disability	24 Months	To prospectively quantify seizure frequency over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization	24 months	To prospectively quantify healthcare utilization
Medication changes	24 months	To prospectively quantify medication changes over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.

Trial Locations

Locations (10)

Idaho Comprehensive Epilepsy Center; 🇺🇸 Boise, Idaho, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Northwell Health Comprehensive Epilepsy Center; 🇺🇸 New York, New York, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Minnesota Epilepsy Group; 🇺🇸 Saint Paul, Minnesota, United States

Yale Comprehensive Epilepsy Center; 🇺🇸 New Haven, Connecticut, United States

Vanderbilt Epilepsy Center; 🇺🇸 Nashville, Tennessee, United States

New York University; 🇺🇸 New York, New York, United States