Back to resultsLacosamide in Neonatal Status Epilepticus
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lacosamide
Phenobarbital
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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
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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