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

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ClinicalTrials.gov Identifier: NCT03531008
Recruitment Status : Active, not recruiting
First Posted : May 21, 2018
Last Update Posted : February 3, 2021
Sponsor:
Collaborators:
The Epilepsy Study Consortium
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
Epilepsy Foundation of America

Tracking Information
First Submitted Date April 25, 2018
First Posted Date May 21, 2018
Last Update Posted Date February 3, 2021
Actual Study Start Date May 7, 2018
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 8, 2018)
  • 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.
  • Healthcare utilization [ Time Frame: 24 months ]
    To prospectively quantify healthcare utilization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Human Epilepsy Project 2: Resistant Focal Seizures Study
Official Title Biomarkers, Health Outcomes and Healthcare Utilization in People With Resistant Focal Epilepsy
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • Epilepsy
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Biomarkers
Intervention Not Provided
Study Groups/Cohorts Treatment-resistant focal epilepsy
Individuals with treatment-resistant focal epilepsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 8, 2018)
205
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Finland
 
Administrative Information
NCT Number NCT03531008
Other Study ID Numbers HEP2/TM0020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: 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
Responsible Party Epilepsy Foundation of America
Study Sponsor Epilepsy Foundation of America
Collaborators
  • The Epilepsy Study Consortium
  • UCB Biopharma S.P.R.L.
Investigators
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
PRS Account Epilepsy Foundation of America
Verification Date February 2021