Comparison of the effect of two drugs Levetiracetam and Na-valproate in the treatment of generalized tonic clonic seizures in children aged 5-13 years old admitted to Amirkola Hospital
Comparison of the effect of two drugs Levetiracetam and Na-valproate in the treatment of generalized tonic clonic seizures in children aged 5-13 years old admitted to Amirkola hospital
Design
Clinical trials with community based and pragmatic control group, with parallel groups, single blind, randomized,
Settings and conduct
Among children aged 5 to 13 years with generalized tonic seizures who visit the Amirkola children's hospital, 60 cases were randomly selected and then randomly divided into two groups. sodium valproate is given to group A and Levetiracetam is given to group B. People eligible for inclusion are not aware of the used drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 5 to 13 years old, children Suffering generalized tonic clonic seizure and Exclusion criteria criteria: Electrolyte imbalance in creatinine and blood urea nitrogen, drug sensitivity or appropriate drug intolerance.
Intervention groups
Intervention group: Levetiracetam 250 to 500 mg once day for 3 to 6 months.
Control group: Sodium valproate 200 to 500 mg once day for 3 to 6 months.
Main outcome variables
Recurrence of seizure, EEG, Imaging
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190108042287N1
Registration date:2019-02-16, 1397/11/27
Registration timing:registered_while_recruiting
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Faezeh Bolboli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
f.bolboli@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two drugs Levetiracetam and Na-valproate in the treatment of generalized tonic clonic seizures in children aged 5-13 years old admitted to Amirkola Hospital
Public title
Comparison of the effect of two drugs Levetiracetam and Na-valproate in the treatment of generalized tonic clonic seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5-13 years old
Children suffering generalized tonic-clonic seizures
Exclusion criteria:
Electrolyte imbalance in creatinine and urea nitrogen blood
Sensitivity to drug
Age
From 5 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The drug Levetiracetam and Na-valproate were placed in two containers A and B and the medicine was given to patients according to a randomized table. The researcher considered the numbers from 0-24 and 25-49 for the Levetiracetam group and the Na-valproate group, respectively. Then, the researcher will select one of the numbers and move in the preset direction and record the numbers and assign them to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Levetiracetam and Na-valproate tablets are located in two containers A and B, and the people eligible for inclusion are not aware of the used drug, and the drug was given to patients based on a randomized number table.
Placebo
Not used
Assignment
Parallel
Other design features
.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.195
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40.4
ICD-10 code description
Lennox-Gastaut syndrome
Primary outcomes
1
Description
Recurrence of seizure
Timepoint
Every 6 months for one year
Method of measurement
Using EEG
Secondary outcomes
empty
Intervention groups
1
Description
Orally levetiracetam with a dose of 250-500 milligram (mg) for 3 to 6 months
Category
Treatment - Drugs
2
Description
Orally sodium valproate with a dose of 200-500 mg for 3 to 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital of Amirkola Babol
Full name of responsible person
Dr. Mohammad Reza Salehiomran
Street address
Dar ul Shafa Arghavan, Imam Khomeini Arghavan (RA), Amirkola, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3234 2152
Email
salehiomran@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
Rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Salehiomran
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dar ul Shafa Arghavan, Imam Khomeini Arghavan (RA), Amirkola, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3234 2152
Email
salehiomran@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Faezeh Bolboli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
faezeh.bolboli@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Salehiomran
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dar ul Shafa Avenue, Imam Khomeini Avenue (RA), Amirkola, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 981132342152
Email
salehiomran@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD