Human Epilepsy Project 2: Resistant Focal Seizures Study

Epilepsy Clinical Trial

— HEP2  

Official title:

Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531008
• Other study ID #: HEP2/TM0020
• Status: Completed
• Start date: May 7, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: Epilepsy Foundation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: September 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Brain Diseases
• Central Nervous System Diseases
• Epilepsy
• Nervous System Diseases

Locations

Country	Name	City	State
United States	Idaho Comprehensive Epilepsy Center	Boise	Idaho
United States	University of Miami	Miami	Florida
United States	Vanderbilt Epilepsy Center	Nashville	Tennessee
United States	Yale Comprehensive Epilepsy Center	New Haven	Connecticut
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	Mayo Clinic	Rochester	Minnesota
United States	Minnesota Epilepsy Group	Saint Paul	Minnesota
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Epilepsy Foundation of America	The Epilepsy Study Consortium, UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Although we are not doing these analyses as part of this study, we plan future studies that would include genomics, proteomics, and metabolomics analyses on these samples. We will also make the sample available to other approved researchers upon request and review.	24 months
Primary	Seizure freedom rates, seizure frequency and degree of disability	To prospectively quantify seizure frequency over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.	24 Months
Secondary	Medication changes	To prospectively quantify medication changes over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.	24 months
Secondary	Healthcare utilization	To prospectively quantify healthcare utilization	24 months