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

Sponsor
ayesha tariq (Other)
Overall Status
Recruiting
CT.gov ID
NCT04829838
Collaborator
King Edward Medical University (Other)
244
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
10.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: intravenous levetireacetam
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus
Actual Study Start Date :
Jul 25, 2019
Anticipated Primary Completion Date :
Jul 26, 2021
Anticipated Study Completion Date :
Jul 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intravenous levetireacetam

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)

Drug: intravenous levetireacetam
phenytoin is considered as control drug in the study
Experimental: intravenous phenytoin

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

Drug: intravenous levetireacetam
phenytoin is considered as control drug in the study

Outcome Measures

Primary Outcome Measures

  1. comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus [48 hours]

    the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ayesha Tariq Lahore Punjab Pakistan

Sponsors and Collaborators

  • ayesha tariq
  • King Edward Medical University

Investigators

  • Principal Investigator: Haroon Hamid, MBBS,FCPS, King Edward Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ayesha tariq, Post graduate resident in Pediatrics medicine(MD Paeds), King Edward Medical University
ClinicalTrials.gov Identifier:
NCT04829838
Other Study ID Numbers:
  • 700/RC/KEMU
First Posted:
Apr 2, 2021
Last Update Posted:
Apr 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ayesha tariq, Post graduate resident in Pediatrics medicine(MD Paeds), King Edward Medical University
status epilepticus, children, phenytoin, levetireacetam
Additional relevant MeSH terms:
Status Epilepticus

Study Results

No Results Posted as of Apr 2, 2021