EpilepsyHEP2NCT03531008
Human Epilepsy Project 2: Resistant Focal Seizures Study
An observational study of Epilepsy and Brain Diseases, run by Epilepsy Foundation of America at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Epilepsy, Brain Diseases, Central Nervous System Diseases
- How many people
- 157 participants
- Where
- 10 sitesUnited States
- Study dates
- 7 May 2018to 30 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include a cohort of 205 individuals with focal epilepsy who meet the ILAE definition of treatment resistance.
Who may be able to join
- 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
Who cannot join
- 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
- 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
Show all 10Show fewer
- 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
- Medical, psychiatric or psychosocial condition that would be expected to interfere with the conduct of the study
- Enrolled in any interventional study that required a blinded portion or involves a non-FDA approved drug or device
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Idaho Comprehensive Epilepsy Center
Boise, Idaho, 83702
University of Miami
Miami, Florida, 33136
Vanderbilt Epilepsy Center
Nashville, Tennessee, 37232
Yale Comprehensive Epilepsy Center
New Haven, Connecticut, 06520
New York University
New York, New York, 10016
Northwell Health Comprehensive Epilepsy Center
New York, New York, 10075
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55102
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy
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.
Read the 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
- Keywords
- focal; partial
- Medical subject headings
- Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-resistant focal epilepsy | Individuals with treatment-resistant focal epilepsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Secondary outcomes (2)
Medication changes
To prospectively quantify medication changes over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.
Measured: 24 months
Healthcare utilization
To prospectively quantify healthcare utilization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start7 May 2018
- Primary completion30 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Epilepsy Foundation of America
- Sponsor type
- University, hospital or other
- Collaborators
- The Epilepsy Study Consortium, UCB Biopharma S.P.R.L.
- Responsible party
- Sponsor
- Investigators
- Brandy Fureman, PhD, Principal investigator, Epilepsy FoundationJacqueline French, MD, Principal investigator, New York UniversityRuben Kuzniecky, MD, Principal investigator, Northwell HealthDaniel Lowenstein, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531008
- Sponsor's protocol ID
- HEP2/TM0020
- Acronym
- HEP2
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2018
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No protected health information is stored in the HEP2 database, and participants are tracked using their unique Participant Identifier only. All requests for data and specimen utilization (via collaboration with HEP2 investigators) will be submitted using a standardized form that will be available on the HEP2 website, and will be modeled on those used in the Gene Discovery in Epilepsy project (epi4k.org). These requests will be reviewed by the HEP2 PIs, and agreement to pursue collaborations and sharing of specimens will be based on: 1) strong scientific justification for the proposed collaborative project; 2) attestation by collaborators that all safeguards related to patient confidentiality and distribution of specimens will be upheld; and 3) track record of collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy
- ClinicalTrials.gov ID
- NCT03531008
- Acronym / sponsor ID
- HEP2 / HEP2/TM0020
- Conditions
- Epilepsy, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Biomarkers
- Keywords
- focal; partial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Epilepsy Foundation of AmericaUniversity, hospital or other
- Collaborators
- The Epilepsy Study Consortium, UCB Biopharma S.P.R.L.
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-resistant focal epilepsy | – | –Individuals with treatment-resistant focal epilepsy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include a cohort of 205 individuals with focal epilepsy who meet the ILAE definition of treatment resistance.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Has completed a pre-surgical evaluation and intends to pursue surgery in the near term
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seizure freedom rates, seizure frequency and degree of disability
Time frame: 24 Months
To prospectively quantify seizure frequency over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.
2 secondary outcomes
Medication changes
Time frame: 24 months
Healthcare utilization
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Yes. No protected health information is stored in the HEP2 database, and participants are tracked using their unique Participant Identifier only. All requests for data and specimen utilization (via collaboration with HEP2 investigators) will be submitted using a standardized form that will be available on the HEP2 website, and will be modeled on those used in the Gene Discovery in Epilepsy project (epi4k.org). These requests will be reviewed by the HEP2 PIs, and agreement to pursue collaborations and sharing of specimens will be based on: 1) strong scientific justification for the proposed collaborative project; 2) attestation by collaborators that all safeguards related to patient confidentiality and distribution of specimens will be upheld; and 3) track record of collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandy Fureman, PhD principal investigator
Epilepsy Foundation
Jacqueline French, MD principal investigator
New York University
Ruben Kuzniecky, MD principal investigator
Northwell Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Brain Diseases, run by Epilepsy Foundation of America at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure freedom rates, seizure frequency and degree of disability (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.