Prospective Regional Epilepsy Database (PREDICT)

Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Johan Zelano, MD PhD; Phone Number: +46313421000; Email: johan.zelano@vgregion.se

Study Locations

• Sweden
  • Borås, Sweden
    • Recruiting
    • Södra Älvsborgs Sjukhus
    • Contact: Markus Karlander, MD; Email: markus.karlander@vgregion.se
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Johan Zelano, MD; Email: johan.zelano@vgregion.se
  • Gothenburg, Sweden
    • Recruiting
    • Sjukhusen i Väster
    • Contact: Kerstin Andrén; Email: kerstin.anden@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with an unprovoked seizure or epilepsy, resident in VGR at inclusion.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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. Languages available: Swedish, English, Arabic. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epilepsy	more than one seizure after first seizure	baseline and years 1,2,3,4,5,6,7,8,9,10
seizure status	the number of seizures in last two months and overall	baseline and years 1,2,3,4,5,6,7,8,9,10
drug resistant epilepsy	epilepsy that has not responded to two antiepileptic drugs	baseline and years 1,2,3,4,5,6,7,8,9,10
severe side effects of antiepileptic drug		baseline and years 1,2,3,4,5,6,7,8,9,10
psychosocial outcomes	employment, marital status, income, sick leave	baseline and years 1,2,3,4,5,6,7,8,9,10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
received health care	the number of visits for epilepsy, missed appointments, time intervals between visits	baseline and years 1,2,3,4,5,6,7,8,9,10

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Johan Zelano, MD PhD, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: epilepsy; biomarker; quality of care; access to care; seizure
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 2020-00853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be protected by privacy laws and cannot be shared even if anonymized, because of the high resolution of data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No