Prospective Regional Epilepsy Database

Epilepsy Clinical Trial

— PREDICT  

Official title:

Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559919
• Other study ID #: 2020-00853
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: December 31, 2031

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Johan Zelano, MD PhD
• Phone: +46313421000
• Email: johan.zelano[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Sweden	Södra Älvsborgs Sjukhus	Borås
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Sjukhusen i Väster	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epilepsy	more than one seizure after first seizure	baseline and years 1,2,3,4,5,6,7,8,9,10
Primary	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
Primary	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
Primary	severe side effects of antiepileptic drug		baseline and years 1,2,3,4,5,6,7,8,9,10
Primary	psychosocial outcomes	employment, marital status, income, sick leave	baseline and years 1,2,3,4,5,6,7,8,9,10
Secondary	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