EpilepsyNCT03346382
Emergency Medical Services and Epilepsy in Switzerland
An observational study of Epilepsy, run by Theusinger Oliver M..
Trial summary
Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Epilepsy
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Jun 2016
- 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 Up to 99 years
- All sexes
- Child, Adult, Older adult
Study population: retrospective collected data from the emergency medical system "Schutz \& Rettung Zürich", Zurich, Switzerland, over an 18 months period from 01. June 2013 till 31. December 2014 - all calls for epileptic seizures
Who may be able to join
- emergency calls for epileptic seizures received by the emergency medical system of Zurich,Switzerland,
- the use of midazolam or diazepam or no drug used.
Who cannot join
- the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental
About this study
Official title: Treatment of Epilepsy in Children and Adults in the Emergency Medical Services of the City of Zurich, Switzerland - Midazolam Versus Diazepam - A Retrospective Analysis
Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Furthermore, children versus adults were compared. Continuous variables were summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups were compared using the independent samples t-test. P-values < 0.05 are considered significant.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Emergency medical services
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting
In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient.
Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups are compared using the independent samples t-test. P-values < 0.05 are considered significant.
Measured: follow up up to 1 year
Secondary outcomes (1)
Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome
In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient.
Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups are compared using the independent samples t-test. P-values < 0.05 are considered significant.
Measured: follow up up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Mar 2015
- Primary completion31 Dec 2015
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theusinger Oliver M.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Theusinger Oliver M., Balgrist University Hospital
- Investigators
- Oliver M Theusinger, MD, Study chair, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346382
- Sponsor's protocol ID
- OMT 01012015 SRZ
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Epilepsy in Children and Adults in the Emergency Medical Services of the City of Zurich, Switzerland - Midazolam Versus Diazepam - A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03346382
- Acronym / sponsor ID
- OMT 01012015 SRZ
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Emergency medical services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Theusinger Oliver M.University, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 17 Nov 2017 (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.
Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Furthermore, children versus adults were compared. Continuous variables were summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups were compared using the independent samples t-test. P-values < 0.05 are considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- retrospective collected data from the emergency medical system "Schutz \& Rettung Zürich", Zurich, Switzerland, over an 18 months period from 01. June 2013 till 31. December 2014 - all calls for epileptic seizures
Key inclusion criteria (2 listed)
- emergency calls for epileptic seizures received by the emergency medical system of Zurich,Switzerland,
- the use of midazolam or diazepam or no drug used.
Key exclusion criteria (1 listed)
- the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting
Time frame: follow up up to 1 year
In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient. Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median [minimum; maximum]. Groups are compared using the independent samples t-test. P-values < 0.05 are considered significant.
1 secondary outcome
Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome
Time frame: follow up up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Oliver M Theusinger, MD study chair
Balgrist University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Theusinger Oliver M..
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 1 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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting (time frame: follow up up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.