A comparative study on the efficacy of Levetiracetam and Carbamazepine in the treatment of Rolandic seizures in children referred to the pediatric neurology clinics of Imam Hossein hospital- Isfahan University of Medical Sciences in 2019; An open-label randomized controlled trial
Evaluation and comparison of the efficacy of Levetiracetam and Carbamazepine in Rolandic epilepsy patients referred to pediatric neurology clinic of Imam Hossein Hospital of Isfahan University of Medical Sciences in 2019
Design
Randomized, not-blinded, controlled clinical trial with parallel groups
Settings and conduct
This study starts in the winter of 1397 by selecting 94 patients from the patients referred to the Neurology Clinic of Imam Hossein Hospital. They are randomly assigned to two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Children with BECTS (clinical diagnosis and EEG in favor of Rolandic epilepsy) with more than two attacks per year
2) Medicated with only one drug
3) Age above 4 years and under 12 years
4) Normal MRI
Exclusion criteria:
1) Lack of consent to enter the study
2) Severe side effects and drug reactions to Levetiracetam or Carbamazepine
3) Multi-drug therapy
4) Inability to follow up the patients
Intervention groups
Patients, depending on their groups, treated with Levebel syrup (100 mg/ml) at a dose of 30 mg//kg/day or Tegretol 20 mg/kg for 6 months
Main outcome variables
frequency, duration and severity of seizure attacks and drug side effects before treatment and every two months for 6 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190208042654N3
Registration date:2020-01-07, 1398/10/17
Registration timing:registered_while_recruiting
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Vahid Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 3653
Email address
v.mansoury@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the efficacy of Levetiracetam and Carbamazepine in the treatment of Rolandic seizures in children referred to the pediatric neurology clinics of Imam Hossein hospital- Isfahan University of Medical Sciences in 2019; An open-label randomized controlled trial
Public title
The Comparison of efficacy of Levetiracetam and Carbamazepine in the treatment of Rolandic seizures in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with BECTS (clinical diagnosis and EEG in favor of Rolandic epilepsy) with more than two attacks per year
Medicated with only one drug
Age above 4 years under 12 years and
Normal MRI
Exclusion criteria:
Lack of consent to enter the study
Severe side effects and drug reactions to Levetiracetam or Carbamazepine
Multi-drug therapy
Inability to follow up the patients
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 94 patients will be selected consecutively, if they meet the criteria for entry, from the patients admitted to the neurology clinic of Imam Hossein children hospital. Then, they are assigned randomly to two groups by binary blocks. The randomization process is done by using a random numbered table to reach the desired sample number.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.349
Health conditions studied
1
Description of health condition studied
Rolandic seizure
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Frequency, duration, and severity of seizure attacks and drug side effects
Timepoint
before treatment and every two months for 6 months
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Levetiracetam group treated with Lovebel syrup (100 mg/ml) with 30 mg/kg/day for 6 months
Category
Treatment - Drugs
2
Description
Control group: Carbamazepine group treated with Tegertol 20 mg/kg for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Parastou Ahadi
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 8247
Email
Dr.ahadi65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Jafar Nasiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Nasiri.jafar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jafar Nasiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Nasiri.jafar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jafar Nasiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Nasiri.jafar@gmail.com
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