Epilepsy in ChildrenLEVETNCT06498362
The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children
An observational study of Epilepsy in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Epilepsy in Children
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2023to 16 May 2025
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Minor patient aged 3 months to 17 years having 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
Who may be able to join
- Minor patient aged 3 months to 17 years
- 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
- Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023
- Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research.
Who cannot join
- Patient or parents having expressed their opposition to participating in the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Sarah BAER, MD, 33 3 88 12 63 98, sarah.baer@chru-strasbourg.fr
Sarah BAER, MD
About this study
Official title: The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old
Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.
The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus
- Conditions
- Epilepsy in Children
- Keywords
- Epilepsy, Epilepsy in Children
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
The non-inferiority of LEVETIRCETAM in comparison with PHENYTOIN is based on a composite primary endpoint consisting of the total duration of the seizure, the need for another antiepileptic treatment to resolve the seizure or recurrence within 24 hours. following the start of treatment for a new status epilepticus and the total duration of hospitalization.
The need for another antiepileptic drug or recurrence is a binary variable with presence (= yes = 1) or absence (= no = 0).
The total duration of the crisis is expressed in minutes, and corresponds to the interval between the identification of the event and the objectification of its cessation.
The total duration of hospitalization is expressed in days, and corresponds to the duration between the first day of hospitalization (regardless of the location) and the day of discharge (regardless of the department).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start16 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completion16 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498362
- Sponsor's protocol ID
- 9067
- Acronym
- LEVET
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old
- ClinicalTrials.gov ID
- NCT06498362
- Acronym / sponsor ID
- LEVET / 9067
- Conditions
- Epilepsy in Children
- Keywords
- Epilepsy, Epilepsy in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- 16 May 2025 (estimated)
- First posted
- 12 Jul 2024 (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.
Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.
The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minor patient aged 3 months to 17 years having 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
Key inclusion criteria (4 listed)
- Minor patient aged 3 months to 17 years
- 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
- Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023
- Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research.
Key exclusion criteria (1 listed)
- Patient or parents having expressed their opposition to participating in the study.
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
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
Time frame: Up to 2 years
The non-inferiority of LEVETIRCETAM in comparison with PHENYTOIN is based on a composite primary endpoint consisting of the total duration of the seizure, the need for another antiepileptic treatment to resolve the seizure or recurrence within 24 hours. following the start of treatment for a new status epilepticus and the total duration of hospitalization. The need for another antiepileptic drug or recurrence is a binary variable with presence (= yes = 1) or absence (= no = 0). The total duration of the crisis is expressed in minutes, and corresponds to the interval between the identification of the event and the objectification of its cessation. The total duration of hospitalization is expressed in days, and corresponds to the duration between the first day of hospitalization (regardless of the location) and the day of discharge (regardless of the department).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
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 in Children, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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 France. 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 Sarah BAER, MD (33 3 88 12 63 98, sarah.baer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN (time frame: Up to 2 years). 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 12 Jul 2024.