Prospective Regional Epilepsy Database

NCT04559919 | Recruiting

• 1 other identifier: 2020-00853
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Epilepsy

Keywords

epilepsy; biomarker; access to care; quality of care; seizure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• received health care

  baseline and years 1,2,3,4,5,6,7,8,9,10

Study Arms (1)

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; Diagnostic Test: Tests; Other: Epilepsy; Other: Demographics and psychosocial; Other: Health care

Interventions

Seizure status OTHER

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

Adults with epilepsy

Tests DIAGNOSTIC_TEST

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

Adults with epilepsy

Epilepsy 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.

Adults with epilepsy

Demographics and psychosocial 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.

Adults with epilepsy

Health care OTHER

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

Adults with epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Expected survival less than two years
• Inability to give informed consent

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (3)

Södra Älvsborgs Sjukhus

Borås, Sweden

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Sjukhusen i Väster

Gothenburg, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

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).

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Demography; Delivery of Health Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Johan Zelano, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Zelano, MD PhD

CONTACT

+46313421000; johan.zelano@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurologist

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 23, 2020
• Study Start: November 27, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)