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Recruiting NCT04559919

Prospective Regional Epilepsy Database

Observational Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Seizure status, Tests, Epilepsy, Demographics and psychosocial.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • epilepsy [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]
  • seizure status [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]
  • drug resistant epilepsy [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]
  • severe side effects of antiepileptic drug [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]
  • psychosocial outcomes [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]
Secondary outcome measures (1)
  • received health care [Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 3 centers
  • Södra Älvsborgs Sjukhus — Borås
  • Sahlgrenska University Hospital — Gothenburg
  • Sjukhusen i Väster — Gothenburg

Publications

  • Karlander M, Akel S, Idegard A, Andersson K, Zetterberg H, Larsson D, Zelano J. Civilian post-traumatic epilepsy: Clinical and socioeconomic characteristics. Epilepsy Behav. 2026 Sep;182:111107. doi: 10.1016/j.yebeh.2026.111107. Epub 2026 May 20. PMID 42161148
  • Andersson K, Boxum M, Srikrishna M, Malac M, Bjorkman-Burtscher IM, Scholl M, Zelano J. Gray matter volume associations with clinical outcomes in epilepsy: A regional cohort study. Epilepsy Res. 2026 May;223:107781. doi: 10.1016/j.eplepsyres.2026.107781. Epub 2026 Mar 20. PMID 41864089
  • Andersson K, Akel S, Asztely F, Larsson D, Zetterberg H, Zelano J. Higher plasma total tau concentrations among patients reporting CNS-related side effects from antiseizure medication. Seizure. 2025 Feb;125:99-105. doi: 10.1016/j.seizure.2025.01.015. Epub 2025 Jan 13. PMID 39826304

Identifiers

NCT: NCT04559919 · 2020-00853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗