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Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

Primary Purpose

Status Epilepticus

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
intravenous levetireacetam
Sponsored by
ayesha tariq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring status epilepticus, children, phenytoin, levetireacetam

Eligibility Criteria

2 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus

Exclusion Criteria:

  • children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions

Sites / Locations

  • Ayesha TariqRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravenous levetireacetam

intravenous phenytoin

Arm Description

Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)

Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day

Outcomes

Primary Outcome Measures

comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
March 31, 2021
Sponsor
ayesha tariq
Collaborators
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04829838
Brief Title
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
Official Title
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
July 26, 2021 (Anticipated)
Study Completion Date
July 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ayesha tariq
Collaborators
King Edward Medical University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.
Detailed Description
After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
status epilepticus, children, phenytoin, levetireacetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous levetireacetam
Arm Type
Experimental
Arm Description
Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day)
Arm Title
intravenous phenytoin
Arm Type
Experimental
Arm Description
Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day
Intervention Type
Drug
Intervention Name(s)
intravenous levetireacetam
Intervention Description
phenytoin is considered as control drug in the study
Primary Outcome Measure Information:
Title
comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus
Description
the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus Exclusion Criteria: children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ayesha tariq, MBBS
Phone
0923360495413
Email
docayesha86@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohammad Haroon Hamid, MBBS,FCPS
Phone
0923008880916
Email
PROFHAROON@KEMU.EDU.PK
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haroon Hamid, MBBS,FCPS
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayesha Tariq
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ayesha tariq, MBBS
Phone
0923360495413
Email
docayesha86@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27089373
Citation
Smith DM, McGinnis EL, Walleigh DJ, Abend NS. Management of Status Epilepticus in Children. J Clin Med. 2016 Apr 13;5(4):47. doi: 10.3390/jcm5040047.
Results Reference
background
PubMed Identifier
25304961
Citation
Abend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.
Results Reference
background

Learn more about this trial

Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

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