EpilepsyLOSTITNCT07116330
Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
An observational study of Epilepsy and Seizure, run by Sahlgrenska University Hospital at 3 sites in Sweden.
Trial summary
A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)
- How many people
- 420 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Sep 2025to Jun 2035
- How long will I take part?
- 5 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.
Who may be able to join
- Clinical study:
- First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers
- Register study:
- age ≥50 with a first-ever outpatient appointment to one of the participating clinics and
- a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40)
Who cannot join
- Clinical study:
- Inability to consent.
- Progressive brain disease (tumour or degenerative)
- Register study:
- preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation
- a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or
- progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or
- neurocognitive disorders (ICD-10: F00-F03, F051, G30, G318, G912; ATC code: N06D).
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 Älvsborg Sjukhus
Borås
Markus Karlander, MD PhD, +46 33 616 10 00, markus.karlander@vgregion.se
- Recruiting
Salgrenska University Hospital
Gothenburg
David Larsson, MD, 0413421000, david.gw.larsson@vgregion.se
- Recruiting
Skånes universitetssjukhus
Malmö
Petrea Frid, petrea.frid@med.lu.se
About this study
A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown.
The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study.
The project has two interlinked components: a prospective single group study, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level.
Read the detailed description
Cluster design: Participating sites start with vascular risk factor intervention - patients are then offered participation in an observational 1-year study. In addition, all patients at the sites are followed in registers and compared to historic controls. Follow-up in the register study will be at least 5, but probably 10 years (until significant difference in primary analysis - Kaplan Meier).
- Being tested
- Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)
- Keywords
- vascular risk, cardiovascular
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)Other
The vascular risk assessment is outlined below, there may be slight variations according to local routines. Overall, the screening should include:
Family history of vascular disease
Tests/examinations (order or obtain from medical records [past 3 months]) Weight Height Waist circumference 12-lead ECG Resting and standing blood pressure Total cholesterol HDL cholesterol LDL cholesterol HbA1c High sensitivity CRP Serum creatinine Urine albumin-to-creatinine ratio
Medical history Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis
| Study group | Role | What they receive |
|---|---|---|
| First seizure after age 50 | All patients evaluated for a first seizure after age 50 at the providers. Receives: Other: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with pharmacological intervention
The proportion with pharmacological intervention of modifiable vascular risk factors.
Measured: 1 year
Secondary outcomes (2)
Secondary outcomes in prospective clinical study
Proportion (%) with hypertension, diabetes mellitus, moderate to severe chronic kidney disease, atrial fibrillation.
Measured: At recruitment
Secondary outcomes at 1 year follow-up prospective clinical study
Delta (absolute and %) in modifiable vascular risk factors compared to baseline, changes in SCORE2/SCORE2-OP, adverse effects, arrhythmias, retention of pharmacological intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sodra Alvsborgs Hospital, Skane University Hospital, Danderyd Hospital, Uppsala University Hospital
- Responsible party
- Principal investigator, Johan Zelano, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116330
- Sponsor's protocol ID
- 2024-08662
- Acronym
- LOSTIT
- Status last verified
- Feb 2026
- First submitted
- 10 Jun 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy laws and regulations prevent most sharing of data. Anonymized or processed data may be shared upon reasonable request if regulatory possibilities allow.
Publications
Larsson D, Asberg S, Sundstrom J, Frid P, Zelano J. Cardiovascular risk factor assessment in late-onset seizures: A study protocol to assess the value of structured intervention. Epilepsia Open. 2024 Aug;9(4):1611-1617. doi: 10.1002/epi4.12987. Epub 2024 Jun 14.
PubMed 38874366
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
- ClinicalTrials.gov ID
- NCT07116330
- Acronym / sponsor ID
- LOSTIT / 2024-08662
- Keywords
- vascular risk, cardiovascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Sodra Alvsborgs Hospital, Skane University Hospital, Danderyd Hospital, Uppsala University Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 11 Aug 2025 (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.
A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown.
The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study.
The project has two interlinked components: a prospective single group study, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level.
Detailed description
Cluster design: Participating sites start with vascular risk factor intervention - patients are then offered participation in an observational 1-year study. In addition, all patients at the sites are followed in registers and compared to historic controls. Follow-up in the register study will be at least 5, but probably 10 years (until significant difference in primary analysis - Kaplan Meier).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First seizure after age 50 | – | Other: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)All patients evaluated for a first seizure after age 50 at the providers. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.
Key inclusion criteria (5 listed)
- First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers
- age ≥50 with a first-ever outpatient appointment to one of the participating clinics and
- a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40)
Key exclusion criteria (8 listed)
- Inability to consent.
- Progressive brain disease (tumour or degenerative)
- preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation
- a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or
- progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or
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 |
|---|---|---|
| Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)The vascular risk assessment is outlined below, there may be slight variations according to local routines. Overall, the screening should include: Family history of vascular disease Tests/examinations (order or obtain from medical records [past 3 months]) Weight Height Waist circumference 12-lead ECG Resting and standing blood pressure Total cholesterol HDL cholesterol LDL cholesterol HbA1c High sensitivity CRP Serum creatinine Urine albumin-to-creatinine ratio Medical history Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis | Other | First seizure after age 50 |
Primary outcome
Proportion with pharmacological intervention
Time frame: 1 year
The proportion with pharmacological intervention of modifiable vascular risk factors.
2 secondary outcomes
Secondary outcomes in prospective clinical study
Time frame: At recruitment
Secondary outcomes at 1 year follow-up prospective clinical study
Time frame: 1 year
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 3 Mar 2026.
- Background: PubMed 38874366Larsson D, Asberg S, Sundstrom J, Frid P, Zelano J. Cardiovascular risk factor assessment in late-onset seizures: A study protocol to assess the value of structured intervention. Epilepsia Open. 2024 Aug;9(4):1611-1617. doi: 10.1002/epi4.12987. Epub 2024 Jun 14.
- Individual participant dataSharing planned: No. Privacy laws and regulations prevent most sharing of data. Anonymized or processed data may be shared upon reasonable request if regulatory possibilities allow.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
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 and Seizure, 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 5 inclusion and 8 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 3 Mar 2026. 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@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with pharmacological intervention (time frame: 1 year). 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 NCT07116330, which also lists 1 linked publication.
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 3 Mar 2026.