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:
  • lacosa
  • Active Comparator: Phenobarbitone

    Phenobarbital will be given

    Drug: Phenobarbital
    phenobarbital will be given
    Other Names:
  • phenobarbitone
  • Outcome Measures

    Primary Outcome Measures

    1. 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:

    Study Results

    No Results Posted as of Mar 22, 2022