Comparison of the Safety and Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures
Design
A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 54 neonates with refractory siezure, using www.sealedenvelope.com for randomization.
Settings and conduct
This study was conducted in two centers, Ali Asghar and Firozabadi hospital. Neonates with refractory seizures were randomly assigned into two groups. In the first group, neonates received oral Lacosamide and in the second group, neonates received oral Topiramate. In this study, blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Newborn with seizure who did not respond to phenobarbital (dose 20 mg/kg) and Levebel (40 mg/kg), Infants under 3 months with refractory seizures whose seizures have started since infancy (under one month), Seizures due to secondary abnormalities in asphyxia, brain structural disorders, familial seizures, congenital and acquired infections, vascular lesions.
Exclusion criteria: Seizures that started after neonatal period, Seizures due to secondary abnormalities in metabolic disorders or electrolyte disorders.
Intervention groups
In the first intervention group infants receive Lacosamide tablets twice a day at a dosage of 2 mg/kg/day. In The second intervention group Infants receive Topiramate tablets twice a day at a dosage of 5 mg/kg/day.
Main outcome variables
Frequency of seizure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230415057911N2
Registration date:2024-03-16, 1402/12/26
Registration timing:retrospective
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Mohammad Vafaeeshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
vafaeeshahi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Safety and Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures
Public title
Efficacy of Lacosamide and Topiramate on Control of Neonatal Refractory Seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with seizure who did not respond to phenobarbital (dose40 mg/kg) and Levebel (40 mg/kg).
Infants under 3 months with refractory seizures whose seizures have started since infancy (under one month).
Seizures due to secondary abnormalities in asphyxia, brain structural disorders, familial seizures, congenital and acquired infections, vascular lesions
Exclusion criteria:
Seizures that started after neonatal Period
Seizures due to secondary abnormalities in metabolic disorders or electrolyte disorders.
Age
From 1 day old to 3 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization with block size of 4 and 6 used.generation of random sequence was done using www.sealedenvelope.com website. The the random list were provided to a epidemiologist who had no involvement to selection drug. Then subjects were randomly assigned into two groups of Locasamaid and Topiramate.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences; Next to the Milad Tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.IUMS.FMD.REC.1401.689
Health conditions studied
1
Description of health condition studied
Neonatal Seizure
ICD-10 code
P90
ICD-10 code description
Convulsions of newborn
Primary outcomes
1
Description
The incidence of seizures
Timepoint
Before the intervention, 3 days and 7 days after the intervention
Method of measurement
Electroencephalography (EEG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Infants receive Lacosamide tablets (manufactured by Dr. Abidi Company, Iran) twice a day at a dosage of 2 mg/kg/day, If no treatment response, 2 mg/kg is added to the previous dosage every 48 hours until the dose reaches 12 mg/kg, and if a neonate does not respond to the treatment within 48 hours after receiving dosage of 12 mg/kg, the drug is stopped.
Category
Treatment - Drugs
2
Description
Intervention group 2: Infants receive Topiramate tablets (manufactured by Aria Company, Iran) twice a day at a dose of 5 mg/kg/day. If no treatment response, 1 mg/kg is added to the previous dosage every 48 hours until we reach to dosage of 10 mg/kg, and if a neonate does not respond to the treatment until 48 hours after receiving the dose of 10 mg/kg, the drug is stopped. .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Mohammad Vafaeeshahi
Street address
No.193, Zafar St, Modares Highway.
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
vafaeeshahi.m@iums.ac.ir
2
Recruitment center
Name of recruitment center
Firoozabadi Hospital
Full name of responsible person
Mohammad Vafaeeshahi
Street address
Before Shahr Ray Square; Fedayian Islam Street; Shahr-e-Ray
City
Tehran
Province
Tehran
Postal code
1849794113
Phone
+98 21 4055 6434
Email
vafaeeshahi.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
5th Floor of Setad Building, Next to the Milad Tower, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Vafaeeshahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ali-e-Asghar Pediatric Hospital, No. 193, Modares Highway, Zafar street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
vafaeeshahi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Vafaeeshahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ali-e-Asghar Pediatric Hospital, No. 193, Modares Highway, Zafar street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
vafaeeshahi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Vafaeeshahi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ali-e-Asghar Pediatric Hospital, No. 193, Modares Highway, Zafar street
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
vafaeeshahi.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available