Prospective Regional Epilepsy Database

NCT ID: NCT04559919

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-27

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Seizure status

Intervention Type OTHER

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

Tests

Intervention Type DIAGNOSTIC_TEST

We will collect results from imaging, electroencephalogram, and laboratory tests.

Epilepsy

Intervention Type OTHER

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.

Demographics and psychosocial

Intervention Type OTHER

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.

Health care

Intervention Type OTHER

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

Interventions

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Seizure status

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

Intervention Type OTHER

Tests

We will collect results from imaging, electroencephalogram, and laboratory tests.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type OTHER

Health care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johan Zelano

Consultant Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Zelano, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Södra Älvsborgs Sjukhus

Borås, , Sweden

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Sjukhusen i Väster

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Johan Zelano, MD PhD

Role: CONTACT

+46313421000

Facility Contacts

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Markus Karlander, MD

Role: primary

Johan Zelano, MD

Role: primary

Kerstin Andrén

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39826304 (View on PubMed)

Other Identifiers

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2020-00853

Identifier Type: -

Identifier Source: org_study_id

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