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Human Epilepsy Project 2: Resistant Focal Seizures Study (HEP2)

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ClinicalTrials.gov Identifier: NCT03531008
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
The Epilepsy Study Consortium
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
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.

Condition or disease
Epilepsy

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 4 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. The study has one international site in Finland. 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 three in person visits at the beginning of the study, after the first year, and a final visit after the second year.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020


Group/Cohort
Treatment-resistant focal epilepsy
Individuals with treatment-resistant focal epilepsy



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Medication changes [ Time Frame: 24 months ]
    To prospectively quantify medication changes over a 24 month period in a cohort of adults with treatment resistant focal epilepsy.

  2. Healthcare utilization [ Time Frame: 24 months ]
    To prospectively quantify healthcare utilization


Other Outcome Measures:
  1. Biomarkers [ Time Frame: 24 months ]
    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.


Biospecimen Retention:   Samples With DNA
Blood samples will be collected at the first visit and the final visit. A third sample may be collected from those participants who experience a seizure-free period of three months or more during the study period. All blood samples will be retained indefinitely, for use in future research. The specific details of future studies are unknown at this time, but will include genomic, proteomic, metabolomic and transcriptome analyses.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include a cohort of 205 individuals with focal epilepsy who meet the ILAE definition of treatment resistance.
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 ≥ 4 focal seizures/month, including auras, and at least 2 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. Intent to pursue surgical resection intervention in the next two years
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531008


Contacts
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Contact: Brandy Fureman, PhD 1-800-332-1000 BFureman@efa.org
Contact: Sabrina Cristofaro, R.N., B.S.N. 646-754-2227 Sabrina.Cristofaro@nyumc.org

Locations
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United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Rebecka Craig    415-353-3738    rebecka.craig@ucsf.edu   
Principal Investigator: Manu Hegde, MD, PhD         
United States, Connecticut
Yale Comprehensive Epilepsy Center Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Jennifer Bonito    203-785-3638    jennifer.bonito@yale.edu   
Contact: Jane Obryan    203-785-3638    jane.obryan@yale.edu   
Principal Investigator: Kamil Detyniecki, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Sherry Klingerman    507-284-0451    klingerman.sherry@mayo.edu   
Principal Investigator: Gregory Cascino, MD         
Minnesota Epilepsy Group Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Jennifer Pohlman, MBS    651-241-5304    jpohlman@mnepilepsy.net   
Principal Investigator: Paul Atkinson, MD         
United States, New York
New York University Not yet recruiting
New York, New York, United States, 10016
Contact: Aaron Smith    646-558-0810    Aaron.Smith2@nyumc.org   
Principal Investigator: Manisha Holmes, MD         
Northwell Health Comprehensive Epilepsy Center Recruiting
New York, New York, United States, 10075
Contact: Martha Karran       mkarran@northwell.edu   
Principal Investigator: Ruben Kuzniecky, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ashlie Jefferson    215-662-7227    Ashlie.Jefferson@uphs.upenn.edu   
Contact: Kelly Ca    215-662-7227    kelly.ca@uphs.upenn.edu   
Principal Investigator: Michael Gelfand, MD, PhD         
United States, Tennessee
Vanderbilt Epilepsy Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Melissa Osborn, RN, BSN    615-322-8817    melissa.osborn@vanderbilt.edu   
Principal Investigator: Bassel Abou-Khalil, MD         
Finland
Kuopio University Hospital Not yet recruiting
Kuopio, Finland
Contact: Pirjo Lavi       pirjo.lavi@kuh.fi   
Principal Investigator: Reetta Kalviainen         
Sponsors and Collaborators
Epilepsy Foundation of America
The Epilepsy Study Consortium
UCB Biopharma S.P.R.L.
Investigators
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Principal Investigator: Brandy Fureman, PhD Epilepsy Foundation
Principal Investigator: Jacqueline French, MD New York University
Principal Investigator: Ruben Kuzniecky, MD Northwell Health
Principal Investigator: Daniel Lowenstein, MD University of California, San Francisco

Additional Information:

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Responsible Party: Epilepsy Foundation of America
ClinicalTrials.gov Identifier: NCT03531008     History of Changes
Other Study ID Numbers: HEP2/TM0020
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will become available for request one year after the database is locked, and will remain available indefinitely.
Access Criteria: 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.
URL: http://www.humanepilepsyproject.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Epilepsy Foundation of America:
focal;

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases