Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
1 other identifier
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2019
CompletedFirst Submitted
Initial submission to the registry
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2021
CompletedApril 2, 2021
March 1, 2021
2 years
March 31, 2021
March 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
48 hours
Study Arms (2)
Intravenous levetireacetam
EXPERIMENTALDrug: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
EXPERIMENTALIntravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day
Interventions
phenytoin is considered as control drug in the study
Eligibility Criteria
You may qualify if:
- childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus
You may not qualify if:
- children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ayesha tariqlead
- King Edward Medical Universitycollaborator
Study Sites (1)
Ayesha Tariq
Lahore, Punjab Province, Pakistan
Related Publications (2)
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.
PMID: 27089373BACKGROUNDAbend NS, Loddenkemper T. Pediatric status epilepticus management. Curr Opin Pediatr. 2014 Dec;26(6):668-74. doi: 10.1097/MOP.0000000000000154.
PMID: 25304961BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haroon Hamid, MBBS,FCPS
King Edward Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Post graduate resident in Pediatrics medicine(MD Paeds)
Study Record Dates
First Submitted
March 31, 2021
First Posted
April 2, 2021
Study Start
July 25, 2019
Primary Completion
July 26, 2021
Study Completion
July 26, 2021
Last Updated
April 2, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share