EpilepsyMAINZ-EPIREGNCT05267405
Mainz Epilepsy Registry
An observational study of Epilepsy and Dissociative Seizures, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Dissociative Seizures, Status Epilepticus
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 31 Jan 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
Who may be able to join
- Epileptic or psychogenic seizures
Who cannot join
- age<18
- patients who cannot provide informed consent and don't have a legal guardian
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Mainz Comprehensive Epilepsy and Sleep Medicine Center
Mainz, Rhineland-Palatinate, 55131
Winter Yaroslav, MD, MSc, +496131172234, yaroslav.winter@unimedizin-mainz.de
About this study
Official title: Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)
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.
Read the detailed description
Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.
- Conditions
- Epilepsy, Dissociative Seizures, Status Epilepticus
- Being tested
- no interventions, only observation
- Medical subject headings
- Epilepsy, Psychogenic Nonepileptic Seizures, Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventions, only observationOther
no interventions, only observation
What is being measured
The primary outcome is the main question the study is designed to answer.
monthly seizure frequency after 6 months
monthly seizure frequency at the follow-up after 6 months
Measured: 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)
Measured: 6 months
monthly seizure frequency after 12 months
monthly seizure frequency at the follow-up after 12 months
Measured: 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)
Measured: 12 months
Seizure freedom
percentage of patients without epileptic seizures
Measured: 6 months
Seizure freedom
percentage of patients without epileptic seizures
Measured: 12 months
interruption of status epilepticus
percentage of patients with interrupted status epilepticus
Measured: 48 hours
Secondary outcomes (12)
Resilience Scale 13
Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience
Measured: 12 months
Resilience Scale 13
Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience
Measured: 24 months
Multidimensional Fatigue Inventory
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Measured: 12 months
Multidimensional Fatigue Inventory
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Measured: 24 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Measured: 12 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Measured: 24 months
Berlin Social Support Scales (BSSS)
Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support
Measured: 12 months
Berlin Social Support Scales (BSSS)
Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support
Measured: 24 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)
Measured: 12 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)
Measured: 24 months
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality
Measured: 12 months
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Feb 2018
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 700 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yaroslav Winter, Johannes Gutenberg University Mainz
- Investigators
- Yaroslav Winter, MD, MSc, Principal investigator, Mainz Comprehensive Epilepsy and Sleep Medicine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267405
- Sponsor's protocol ID
- MAINZ-EPIREG
- Acronym
- MAINZ-EPIREG
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39096467Winter 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.
PubMed 37784006
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)
- ClinicalTrials.gov ID
- NCT05267405
- Acronym / sponsor ID
- MAINZ-EPIREG / MAINZ-EPIREG
- Conditions
- Epilepsy, Dissociative Seizures, Status Epilepticus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 4 Mar 2022 (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.
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.
Detailed description
Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
Key inclusion criteria (1 listed)
- Epileptic or psychogenic seizures
Key exclusion criteria (2 listed)
- age<18
- patients who cannot provide informed consent and don't have a legal guardian
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 |
|---|---|---|
| no interventions, only observationno interventions, only observation | Other | – |
Primary outcome
monthly seizure frequency after 6 months
Time frame: 6 months
monthly seizure frequency at the follow-up after 6 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
Time frame: 6 months
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)
monthly seizure frequency after 12 months
Time frame: 12 months
monthly seizure frequency at the follow-up after 12 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
Time frame: 12 months
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)
Seizure freedom
Time frame: 6 months
percentage of patients without epileptic seizures
Seizure freedom
Time frame: 12 months
percentage of patients without epileptic seizures
interruption of status epilepticus
Time frame: 48 hours
percentage of patients with interrupted status epilepticus
12 secondary outcomes
Resilience Scale 13
Time frame: 12 months
Resilience Scale 13
Time frame: 24 months
Multidimensional Fatigue Inventory
Time frame: 12 months
Multidimensional Fatigue Inventory
Time frame: 24 months
Beck Depression Inventory II
Time frame: 12 months
Beck Depression Inventory II
Time frame: 24 months
Berlin Social Support Scales (BSSS)
Time frame: 12 months
Berlin Social Support Scales (BSSS)
Time frame: 24 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 12 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 24 months
Pittsburgh Sleep Quality Index
Time frame: 12 months
Pittsburgh Sleep Quality Index
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 39096467Winter 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.
- Derived from this study: PubMed 37784006Winter 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.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Yaroslav Winter, MD, MSc principal investigator
Mainz Comprehensive Epilepsy and Sleep Medicine Center
1 site 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 Dissociative Seizures, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaroslav Winter, MD, MSc (+496131172234, yaroslav.winter@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monthly seizure frequency after 6 months (time frame: 6 months). The study lists 7 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 NCT05267405, which also lists 2 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 4 Mar 2022.