Lacosamide in Neonatal Status Epilepticus
Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT05291455
Collaborator
(none)
60
1
2
25
2.4
Study Details
Study Description
Brief Summary
Lacosamide in neonatal status epilepticus
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
The study will assess the efficacy of Lacosamide in neonatal status epilepticus
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study
Actual Study Start Date
:
Mar 1, 2022
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Apr 1, 2024
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lacosamide Lacosamide will be given. |
Drug: Lacosamide
lacosamide will be given
Other Names:
|
Active Comparator: Phenobarbitone Phenobarbital will be given |
Drug: Phenobarbital
phenobarbital will be given
Other Names:
|
Outcome Measures
Primary Outcome Measures
- number of children with cessation or improved duration of status epilepticus [1 year]
the number of children with cessation or improved duration of status epilepticus
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- neonates with status epilepticus
Exclusion Criteria:
- congenital anomalies or organ dysfunction
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kafrelsheikh University | Tanta | Kafrelsheikh | Egypt |
Sponsors and Collaborators
- Sherief Abd-Elsalam
Investigators
- Principal Investigator: abeer salamah, lecturer, Kafrelsheikh University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sherief Abd-Elsalam,
ass prof tropical medicine,
Tanta University
ClinicalTrials.gov Identifier:
NCT05291455
Other Study ID Numbers:
- abeer ped neurology
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: