Human Epilepsy Project 2: Resistant Focal Seizures Study

NCT ID: NCT03531008

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2022-09-30

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.

Conditions

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Biomarkers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment-resistant focal epilepsy

Individuals with treatment-resistant focal epilepsy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Epilepsy Study Consortium

OTHER

Sponsor Role: collaborator

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: collaborator

Epilepsy Foundation of America

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandy Fureman, PhD

Role: PRINCIPAL_INVESTIGATOR

Epilepsy Foundation

Jacqueline French, MD

Role: PRINCIPAL_INVESTIGATOR

New York University

Ruben Kuzniecky, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Daniel Lowenstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Yale Comprehensive Epilepsy Center

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Idaho Comprehensive Epilepsy Center

Boise, Idaho, United States

Mayo Clinic

Rochester, Minnesota, United States

Minnesota Epilepsy Group

Saint Paul, Minnesota, United States

New York University

New York, New York, United States

Northwell Health Comprehensive Epilepsy Center

New York, New York, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt Epilepsy Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

HEP2/TM0020

Identifier Type: -

Identifier Source: org_study_id