NCT05291455

Brief Summary

Lacosamide in neonatal status epilepticus

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 18, 2022

Last Update Submit

March 18, 2022

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lacosamide

EXPERIMENTAL

Lacosamide will be given.

Drug: Lacosamide

Phenobarbitone

ACTIVE COMPARATOR

Phenobarbital will be given

Drug: Phenobarbital

Interventions

LacosamideDRUG

lacosamide will be given

Also known as: lacosa
Lacosamide
PhenobarbitalDRUG

phenobarbital will be given

Also known as: phenobarbitone
Phenobarbitone

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • neonates with status epilepticus

You may not qualify if:

  • congenital anomalies or organ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Tanta, Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

LacosamidePhenobarbital

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • abeer salamah, lecturer

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

abeer salamah, lecturer

CONTACT

00201009221243abeersalamah84@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ass prof tropical medicine

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 22, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)