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Lacosamide in Neonatal Status Epilepticus

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lacosamide
Phenobarbital
Sponsored by
Sherief Abd-Elsalam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • neonates with status epilepticus

Exclusion Criteria:

  • congenital anomalies or organ dysfunction

Sites / Locations

  • Kafrelsheikh UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lacosamide

Phenobarbitone

Arm Description

Lacosamide will be given.

Phenobarbital will be given

Outcomes

Primary Outcome Measures

number of children with cessation or improved duration of status epilepticus
the number of children with cessation or improved duration of status epilepticus

Secondary Outcome Measures

Full Information

First Posted
March 18, 2022
Last Updated
March 18, 2022
Sponsor
Sherief Abd-Elsalam
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1. Study Identification

Unique Protocol Identification Number
NCT05291455
Brief Title
Lacosamide in Neonatal Status Epilepticus
Official Title
Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lacosamide in neonatal status epilepticus
Detailed Description
The study will assess the efficacy of Lacosamide in neonatal status epilepticus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Lacosamide will be given.
Arm Title
Phenobarbitone
Arm Type
Active Comparator
Arm Description
Phenobarbital will be given
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
lacosa
Intervention Description
lacosamide will be given
Intervention Type
Drug
Intervention Name(s)
Phenobarbital
Other Intervention Name(s)
phenobarbitone
Intervention Description
phenobarbital will be given
Primary Outcome Measure Information:
Title
number of children with cessation or improved duration of status epilepticus
Description
the number of children with cessation or improved duration of status epilepticus
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: neonates with status epilepticus Exclusion Criteria: congenital anomalies or organ dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abeer salamah, lecturer
Phone
00201009221243
Email
abeersalamah84@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
abeer salamah, lecturer
Organizational Affiliation
Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh University
City
Tanta
State/Province
Kafrelsheikh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abeer salamah, lecturer
Phone
0201009221243

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lacosamide in Neonatal Status Epilepticus

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