Lacosamide in Neonatal Status Epilepticus | NCT05291455

Studies
Lacosamide in Neonatal Status Epilepticus

NCT05291455

Sponsor

Sherief Abd-Elsalam

Status

Unknown status

Last Update Posted

Mar 22, 2022Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Epilepsy

Interventions

Lacosamide
Phenobarbital

Countries

Egypt

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Mar 18, 2022

First Submission Date that Met QC Criteria

Mar 18, 2022

First Posted Date

Mar 22, 2022Actual

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 18, 2022

Last Update Posted Date

Mar 22, 2022Actual

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

Lacosamide in neonatal status epilepticus

Detailed Description

The study will assess the efficacy of Lacosamide in neonatal status epilepticus

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacosamide	Experimental	Lacosamide will be given.	Drug: Lacosamide
Phenobarbitone	Active Comparator	Phenobarbital will be given	Drug: Phenobarbital

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	lacosamide will be given	Lacosamide	lacosa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of children with cessation or improved duration of status epilepticus	the number of children with cessation or improved duration of status epilepticus	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neonates with status epilepticus

Exclusion Criteria:

congenital anomalies or organ dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abeer salamah, lecturer	Contact	00201009221243		abeersalamah84@yahoo.com

Overall Officials

Name	Affiliation	Role
abeer salamah, lecturer	Kafrelsheikh University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh University	Recruiting	Tanta	Kafrelsheikh		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078334	Lacosamide
D010634	Phenobarbital

Ancestor Terms

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided