EpilepsyPREDICTNCT04559919
Prospective Regional Epilepsy Database
An observational study of Epilepsy, run by Sahlgrenska University Hospital at 3 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Seizure status, Tests and Epilepsy
- How many people
- 1,000 participants
- Where
- 3 sitesSweden
- Study dates
- 27 Nov 2020to 31 Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with an unprovoked seizure or epilepsy, resident in VGR at inclusion.
Who may be able to join
- 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)
Who cannot join
- Expected survival less than two years
- Inability to give informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Södra Älvsborgs Sjukhus
Borås
Markus Karlander, MD, markus.karlander@vgregion.se
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Johan Zelano, MD, johan.zelano@vgregion.se
- Recruiting
Sjukhusen i Väster
Gothenburg
Kerstin Andrén, kerstin.anden@vgregion.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Seizure status, Tests, Epilepsy, Demographics and psychosocial, Health care
- Keywords
- epilepsy, biomarker, access to care, quality of care, seizure
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seizure statusOther
We will collect information on first seizure ever, last seizure ever, number of seizure in last two months.
TestsDiagnostic test
We will collect results from imaging, electroencephalogram, and laboratory tests.
EpilepsyOther
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 psychosocialOther
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 careOther
We will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Seizure status; Diagnostic Test: Tests; Other: Epilepsy; Other: Demographics and psychosocial; Other: Health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
epilepsy
more than one seizure after first seizure
Measured: 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
Measured: 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
Measured: baseline and years 1,2,3,4,5,6,7,8,9,10
severe side effects of antiepileptic drug
Measured: baseline and years 1,2,3,4,5,6,7,8,9,10
psychosocial outcomes
employment, marital status, income, sick leave
Measured: baseline and years 1,2,3,4,5,6,7,8,9,10
Secondary outcomes (1)
received health care
the number of visits for epilepsy, missed appointments, time intervals between visits
Measured: baseline and years 1,2,3,4,5,6,7,8,9,10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start27 Nov 2020
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Zelano, Sahlgrenska University Hospital
- Investigators
- Johan Zelano, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559919
- Sponsor's protocol ID
- 2020-00853
- Acronym
- PREDICT
- Status last verified
- Jun 2025
- First submitted
- 8 Sep 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be protected by privacy laws and cannot be shared even if anonymized, because of the high resolution of data.
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.
PubMed 42161148Andersson 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.
PubMed 41864089Andersson 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.
PubMed 39826304
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Regional Epilepsy Database and Biobank for Individualized Clinical Treatment
- ClinicalTrials.gov ID
- NCT04559919
- Acronym / sponsor ID
- PREDICT / 2020-00853
- Conditions
- Epilepsy
- Keywords
- epilepsy, biomarker, access to care, quality of care, seizure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with epilepsy | – | Other: Seizure status, Diagnostic Test: Tests, Other: Epilepsy, Other: Demographics and psychosocial, Other: Health careAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with an unprovoked seizure or epilepsy, resident in VGR at inclusion.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Expected survival less than two years
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seizure statusWe will collect information on first seizure ever, last seizure ever, number of seizure in last two months. | Other | Adults with epilepsy |
| TestsWe will collect results from imaging, electroencephalogram, and laboratory tests. | Diagnostic test | Adults with epilepsy |
| EpilepsyWe 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 | Adults with epilepsy |
| Demographics and psychosocialWe 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 | Adults with epilepsy |
| Health careWe will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs | Other | Adults with epilepsy |
Primary outcome
epilepsy
Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10
more than one seizure after first seizure
seizure status
Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10
the number of seizures in last two months and overall
drug resistant epilepsy
Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10
epilepsy that has not responded to two antiepileptic drugs
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
employment, marital status, income, sick leave
1 secondary outcome
received health care
Time frame: baseline and years 1,2,3,4,5,6,7,8,9,10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 42161148Karlander 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.
- Derived from this study: PubMed 41864089Andersson 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.
- Derived from this study: PubMed 39826304Andersson 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.
- Individual participant dataSharing planned: No. The data will be protected by privacy laws and cannot be shared even if anonymized, because of the high resolution of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Zelano, MD PhD principal investigator
Sahlgrenska University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Sahlgrenska University Hospital at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Zelano, MD PhD (+46313421000, johan.zelano@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epilepsy (time frame: baseline and years 1,2,3,4,5,6,7,8,9,10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559919, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.