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Prospective Regional Epilepsy Database (PREDICT)

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ClinicalTrials.gov Identifier: NCT04559919
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Johan Zelano, Sahlgrenska University Hospital, Sweden

Study Description
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Brief Summary:
PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

Condition or disease Intervention/treatment
Epilepsy Other: Seizure status Diagnostic Test: Tests Other: Epilepsy Other: Demographics and psychosocial Other: Health care

Detailed Description:

Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in the health care region of western Sweden (VGR) at the time of inclusion.

Baseline data and outcome variables are collected from several patient registries: the electronic medical records system in the health care region VGR and Swedish National Registers of healthcare, income, and employment managed by The National Board of Health and Welfare or Statistics Sweden, both of which are government agencies.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Groups and Cohorts
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Group/Cohort Intervention/treatment
Adults with epilepsy

Adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in VGR at the time of inclusion.

Based on the clinical information, patients can be categorized into relevant groups; single seizure, seizure-free with epilepsy, and drug-resistant epilepsy. Subgroups may also be selected based on age, sex, epilepsy sub-diagnosis, cause of epilepsy, use of a particular antiepileptic drug, or experience of a particular side effect.

 Other: Seizure status
We will collect information on first seizure ever, last seizure ever, number of seizure in last two months.

Diagnostic Test: Tests
We will collect results from imaging, electroencephalogram, and laboratory tests.

Other: Epilepsy
We will collect information on risk factors of epilepsy, cause of epilepsy, epilepsy type/syndrome, medications tried, if the epilepsy is drug resistent, side effects of antiepileptic drugs.

Other: Demographics and psychosocial
We will collect information on age, sex, date of death if applicable, marital status, education level, income type, driving status, employment, benefits, sick leave, number of household members.

Other: Health care
We will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs


Outcome Measures
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Primary Outcome Measures :
  1. epilepsy [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
    more than one seizure after first seizure

  2. seizure status [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
    the number of seizures in last two months and overall

  3. drug resistant epilepsy [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
    epilepsy that has not responded to two antiepileptic drugs

  4. severe side effects of antiepileptic drug [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
  5. psychosocial outcomes [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
    employment, marital status, income, sick leave


Secondary Outcome Measures :
  1. received health care [ Time Frame: baseline and years 1,2,3,4,5,6,7,8,9,10 ]
    the number of visits for epilepsy, missed appointments, time intervals between visits


Biospecimen Retention:   Samples With DNA
Blood samples, and for some individuals cerebrospinal fluid (if lumbar puncture is indicated for clinical reasons, extra csf will be collected).

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with an unprovoked seizure or epilepsy, resident in VGR at inclusion.
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • An unprovoked seizure within the last year or a diagnosis of epilepsy according to the current International League Against Epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years)

Exclusion Criteria:

  • Expected survival less than two years
  • Inability to give informed consent
Contacts and Locations
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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): NCT04559919


Contacts
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Contact: Johan Zelano, MD PhD +46313421000 johan.zelano@vgregion.se

Locations
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Sweden
Södra Älvsborgs Sjukhus Not yet recruiting
Borås, Sweden
Contact: Markus Karlander, MD       markus.karlander@vgregion.se   
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Johan Zelano, MD       johan.zelano@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Johan Zelano, MD PhD Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Johan Zelano, Consultant Neurologist, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04559919    
Other Study ID Numbers: 2020-00853
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be protected by privacy laws and cannot be shared even if anonymized, because of the high resolution of data.

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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 Johan Zelano, Sahlgrenska University Hospital, Sweden:
epilepsy
biomarker
access to care
quality of care
seizure
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases