NCT05267405

Brief Summary

Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

February 1, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

February 11, 2022

Last Update Submit

February 23, 2022

Conditions

EpilepsyDissociative SeizuresStatus Epilepticus

Outcome Measures

Primary Outcomes (7)

  • monthly seizure frequency after 6 months

    monthly seizure frequency at the follow-up after 6 months

    6 months

  • European Quality of Life 5 dimensions Index (EQ 5D Index)

    health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)

    6 months

  • monthly seizure frequency after 12 months

    monthly seizure frequency at the follow-up after 12 months

    12 months

  • European Quality of Life 5 dimensions Index (EQ 5D Index)

    health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)

    12 months

  • Seizure freedom

    percentage of patients without epileptic seizures

    6 months

  • Seizure freedom

    percentage of patients without epileptic seizures

    12 months

  • interruption of status epilepticus

    percentage of patients with interrupted status epilepticus

    48 hours

Secondary Outcomes (12)

  • Resilience Scale 13

    12 months

  • Resilience Scale 13

    24 months

  • Multidimensional Fatigue Inventory

    12 months

  • Multidimensional Fatigue Inventory

    24 months

  • Beck Depression Inventory II

    12 months

  • +7 more secondary outcomes

Interventions

no interventions, only observationOTHER

no interventions, only observation

Eligibility Criteria

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

All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

You may qualify if:

  • Epileptic or psychogenic seizures

You may not qualify if:

  • age\<18
  • patients who cannot provide informed consent and don't have a legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mainz Comprehensive Epilepsy and Sleep Medicine Center

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Related Publications (2)

  • Winter Y, Abou Dargham R, Patino Tobon S, Groppa S, Fuest S. Cenobamate as an Early Adjunctive Treatment in Drug-Resistant Focal-Onset Seizures: An Observational Cohort Study. CNS Drugs. 2024 Sep;38(9):733-742. doi: 10.1007/s40263-024-01109-9. Epub 2024 Aug 3.

    PMID: 39096467DERIVED

  • Winter Y, Sandner K, Vieth T, Gonzalez-Escamilla G, Stuckrad-Barre SV, Groppa S. Third-Generation Antiseizure Medication in the Treatment of Benzodiazepine-Refractory Status Epilepticus in Poststroke Epilepsy: A Retrospective Observational Register-Based Study. CNS Drugs. 2023 Oct;37(10):929-936. doi: 10.1007/s40263-023-01039-y. Epub 2023 Oct 2.

    PMID: 37784006DERIVED

MeSH Terms

Conditions

EpilepsyPsychogenic Nonepileptic SeizuresStatus Epilepticus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSeizuresNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yaroslav Winter, MD, MSc

    Mainz Comprehensive Epilepsy and Sleep Medicine Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaroslav Winter, MD, MSc

CONTACT

+496131172234yaroslav.winter@unimedizin-mainz.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 4, 2022

Study Start

February 1, 2018

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Locations

DE(1)