Clonazepam in Children Status Epilepticus | NCT04287361

Studies
Clonazepam in Children Status Epilepticus

NCT04287361

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 12, 2020Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Epilepticus Status

Interventions

Efficacy of intravenous clonazepam

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2019Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Feb 11, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2020

Last Update Posted Date

Mar 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Loading dose < 0,03 mg/kg		Patient being treated for a status epilepticus who received an initial dose of clonazepam < 0.03 mg / kg	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	Other: Efficacy of intravenous clonazepam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Efficacy of intravenous clonazepam	Other	Efficacy of intravenous clonazepam	Loading dose < 0,03 mg/kg Loading dose ≥ 0,03 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 day

Secondary Outcomes

Measure	Description	Time Frame
need for a second dose of clonazepam	need for a second dose of clonazepam	1 day
duration of seizure	duration of seizure (minutes)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria

● No loading dose of clonazepam

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maxime colmard, résident	University Hospitals of Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013226	Status Epilepticus

Ancestor Terms

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

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Browse Branches

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