Lacosamide in Neonatal Status Epilepticus

NCT ID: NCT05291455

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-04-01

Brief Summary

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Lacosamide in neonatal status epilepticus

Detailed Description

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

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lacosamide

Lacosamide will be given.

Group Type EXPERIMENTAL

Lacosamide

Intervention Type DRUG

lacosamide will be given

Phenobarbitone

Phenobarbital will be given

Group Type ACTIVE_COMPARATOR

Phenobarbital

Intervention Type DRUG

phenobarbital will be given

Interventions

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Lacosamide

lacosamide will be given

Intervention Type DRUG

Phenobarbital

phenobarbital will be given

Intervention Type DRUG

Other Intervention Names

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lacosa phenobarbitone

Eligibility Criteria

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Inclusion Criteria

* neonates with status epilepticus

Exclusion Criteria

* congenital anomalies or organ dysfunction
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

ass prof tropical medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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abeer salamah, lecturer

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

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Kafrelsheikh University

Tanta, Kafrelsheikh, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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abeer salamah, lecturer

Role: CONTACT

00201009221243

Facility Contacts

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abeer salamah, lecturer

Role: primary

0201009221243

Other Identifiers

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abeer ped neurology

Identifier Type: -

Identifier Source: org_study_id

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