Lacosamide in Neonatal Status Epilepticus

March 18, 2022 updated by: Sherief Abd-Elsalam

Efficacy of Lacosamide in Neonatal Status Epilepticus: A Randomized Controlled Study

Lacosamide in neonatal status epilepticus

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Kafrelsheikh
      • Tanta, Kafrelsheikh, Egypt
        • Recruiting
        • Kafrelsheikh University
        • Contact:
          • abeer salamah, lecturer
          • Phone Number: 0201009221243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • neonates with status epilepticus

Exclusion Criteria:

  • congenital anomalies or organ dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of children with cessation or improved duration of status epilepticus
Time Frame: 1 year
the number of children with cessation or improved duration of status epilepticus
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: abeer salamah, lecturer, Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2022

Primary Completion (ANTICIPATED)

March 1, 2024

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • abeer ped neurology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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