NCT06836687

Brief Summary

The present study is a prospective study on the development of seizure frequency, medication adherence, quality of life and cognitive performance after a first epileptic seizure using the new diagnostic criteria for epilepsy of the International League Against Epilepsy of 2014 at the time of diagnosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
149mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2018Aug 2038

Study Start

First participant enrolled

March 1, 2018

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2038

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2038

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

20.1 years

First QC Date

March 19, 2024

Last Update Submit

February 18, 2025

Conditions

Seizure, EpilepticNeuropsychologyOutcome

Keywords

First epileptic seizureDefinition of epilepsyNeuropsychologyoutcome

Outcome Measures

Primary Outcomes (1)

  • Rate of seizure recurrency

    Seizure recurrency is recorded 6 months, 1 year, 3 years, 5 years and 10 years after the first seizure

    10 Years

Secondary Outcomes (10)

  • employment

    10 years

  • Salary

    10 years

  • Driving restriction

    10 Years

  • Verbale Lern- und Merkfähigkeitstest

    10 years

  • Regensburger Wortflüssigkeits-Test

    10 Years

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with an nunprovoked epileptic seizure

You may qualify if:

  • Completion of the 18th year of life
  • first epileptic seizure
  • Ability to understand the patient information and to give written consent
  • Written consent for voluntary participation in the study

You may not qualify if:

  • Chronic drug or alcohol abuse in the last two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

c/o Klinik für Neurologie

Marburg, Hesse, 35043, Germany

RECRUITING

Related Publications (1)

  • Weil J, Linka L, Gurschi M, Kidik SA, Fuchs A, Schoenfeldt R, Zahnert F, Moller L, Menzler K, Kemmling A, Knake S, Habermehl L. The impact of white matter lesions on seizure recurrence after first epileptic seizures in the elderly: a prospective study. Neurol Res Pract. 2025 May 20;7(1):36. doi: 10.1186/s42466-025-00391-2.

    PMID: 40394715DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., attending staff

Study Record Dates

First Submitted

March 19, 2024

First Posted

February 20, 2025

Study Start

March 1, 2018

Primary Completion (Estimated)

April 1, 2038

Study Completion (Estimated)

August 1, 2038

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)