Epilepticus StatusUHAPANCT04287361
Clonazepam in Children Status Epilepticus
An observational study of Epilepticus Status, run by University Hospital, Montpellier at 1 site in France.
Trial summary
•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children. The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Epilepticus Status
- What is being tested?
- Efficacy of intravenous clonazepam
- Type of treatment
- Injection or infusion
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2019to 31 Jan 2020
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: An individual must fulfill all of the following criteria in order to be eligible for study enrollment: * Aged under 16 years * Status epilepticus taken care of at the CHU de Montpellier
Who may be able to join
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged under 16 years
- Status epilepticus taken care of at the CHU de Montpellier
Who cannot join
- ● No loading dose of clonazepam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus
•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.
The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).
Read more
To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.
Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus
•Methods: Monocentric retrospective study including children < 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.
The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.
•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.
Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.
About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.
To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.
- Conditions
- Epilepticus Status
- Being tested
- Efficacy of intravenous clonazepam
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of intravenous clonazepamOther
Efficacy of intravenous clonazepam
| Study group | Role | What they receive |
|---|---|---|
| Loading dose < 0,03 mg/kg | Patient being treated for a status epilepticus who received an initial dose of clonazepam < 0.03 mg / kg Receives: Other: Efficacy of intravenous clonazepam | |
| Loading dose ≥ 0,03 mg/kg | Patient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg Receives: Other: Efficacy of intravenous clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness in stopping seizures
The primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.
Measured: 1 day
Secondary outcomes (11)
need for a second dose of clonazepam
need for a second dose of clonazepam
Measured: 1 day
duration of seizure
duration of seizure (minutes)
Measured: 1 day
type of seizures
type of seizures (focal, generalized);
Measured: 1 day
aetiologies ;
aetiologies (idiopathic, symptomatic)
Measured: 1 day
pre-hospital treatment used
pre-hospital treatment used
Measured: 1 day
whether or not to use a dose greater than one milligram
whether or not to use a dose greater than one milligram
Measured: 1 day
introduction of a maintenance dose
introduction of a maintenance dose
Measured: 1 day
using another antiepileptic drug
using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)
Measured: 1 day
Hospitalization in an intensive care or resuscitation unit
Hospitalization in an intensive care or resuscitation unit
Measured: 1 day
Rate of hospitalization in conventional sector
Rate of hospitalization in conventional sector
Measured: 1 day
introduction of antiepileptic treatment after treatment
introduction of antiepileptic treatment after treatment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start30 Aug 2019
- Primary completion1 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepticus StatusStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime colmard, résident, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287361
- Sponsor's protocol ID
- RECHMPL19_0501
- Acronym
- UHAPA
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus
- ClinicalTrials.gov ID
- NCT04287361
- Acronym / sponsor ID
- UHAPA / RECHMPL19_0501
- Conditions
- Epilepticus Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Feb 2020 (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.
•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.
The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).
To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.
Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus
•Methods: Monocentric retrospective study including children < 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.
The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.
•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.
Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.
About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.
To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loading dose < 0,03 mg/kg | – | Other: Efficacy of intravenous clonazepamPatient being treated for a status epilepticus who received an initial dose of clonazepam < 0.03 mg / kg |
| Loading dose ≥ 0,03 mg/kg | – | Other: Efficacy of intravenous clonazepamPatient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment: * Aged under 16 years * Status epilepticus taken care of at the CHU de Montpellier
Key inclusion criteria (3 listed)
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged under 16 years
- Status epilepticus taken care of at the CHU de Montpellier
Key exclusion criteria (1 listed)
- ● No loading dose of clonazepam
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 |
|---|---|---|
| Efficacy of intravenous clonazepamEfficacy of intravenous clonazepam | Other | Loading dose < 0,03 mg/kg, Loading dose ≥ 0,03 mg/kg |
Primary outcome
effectiveness in stopping seizures
Time frame: 1 day
The primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.
11 secondary outcomes
need for a second dose of clonazepam
Time frame: 1 day
duration of seizure
Time frame: 1 day
type of seizures
Time frame: 1 day
aetiologies ;
Time frame: 1 day
pre-hospital treatment used
Time frame: 1 day
whether or not to use a dose greater than one milligram
Time frame: 1 day
introduction of a maintenance dose
Time frame: 1 day
using another antiepileptic drug
Time frame: 1 day
Hospitalization in an intensive care or resuscitation unit
Time frame: 1 day
Rate of hospitalization in conventional sector
Time frame: 1 day
introduction of antiepileptic treatment after treatment
Time frame: 1 day
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 12 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Epilepticus Status
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Predictors of Outcomes of Convulsive Status Epilepticus
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RecruitingPhase 3
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Status Epilepticus
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.
Maxime colmard, résident principal investigator
University Hospitals of Montpellier
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 Epilepticus Status, run by University Hospital, Montpellier 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 3 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 12 Mar 2020. 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?
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?
effectiveness in stopping seizures (time frame: 1 day). 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 Mar 2020.