Comparison between the effect of carbamazepine and levetiracetam usage in the treatment of children between 6 to 12 years old with Rolandic epilepsy; An open-labeled RCT
Comparison between the effect of carbamazepine & levetiracetam usage in the treatment of children between 6 to 12 years old with Rolandic epilepsy
Design
Two arms parallel-group randomized trial opened labeled, on 88 participants using block randomization using rand function of excel software.
Settings and conduct
patients who were referred with the rolandic syndrome after conducting EEG and verification of the syndrome, participants go under WISC test and then using the randomization patients receive intervention and would be supervised monthly and after 3 months WISC test would be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
children between age 6-12 years old diagnosed with the rolandic syndrome
having no previous history of neurological and/or psychiatric and/or learning and/or genetical disorder(s) previous to the onset of RS
Exclusion criteria:
having a previous history of using Anti-epileptic drugs
Intervention groups
The intervention group includes patients with rolandic epilepsy who receive levetiracetam drug intervention.
The control group includes patients with rolandic epilepsy who receive carbamazepin drug intervention.
Main outcome variables
1. cognitive score
2. rate of epilepsy attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041338N1
Registration date:2022-01-16, 1400/10/26
Registration timing:registered_while_recruiting
Last update:2022-01-16, 1400/10/26
Update count:0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
hamid nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 4508
Email address
meshham5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of carbamazepine and levetiracetam usage in the treatment of children between 6 to 12 years old with Rolandic epilepsy; An open-labeled RCT
Public title
Comparison between the effect of carbamazepine and levetiracetam on children diagnosed with Rolandic epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children between age 6-12 years old (age of onset of disorder and eligible for the cognitive test)
diagnosed with Rolandic syndrome by using vEEG or EEG by a pediatric neurologist or epileptologist
having no previous history of using AEDs (Anti-epileptic drugs)
having no previous history of neurological and/or psychiatric and/or learning and/or genetical disorder(s) previous to the onset of Rolandic syndrome
having no history of using drugs that affect cognitive abilities significantly
signing ethical consent with total awareness and voluntary
Exclusion criteria:
patients who showed any side effects of Carbamazepine (like skin rash, Steven Johnson) and Levetiracetam (like suicide thoughts, acute behavioral problems due to Levetiracetam usage)
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Using Excel software and the Rand function in the software, the statistician of the project, will create a random sequence and hide this randomized allocation before the interventions begin. In this sequence, participants were randomly entered into 22 blocks, each consisting of two girls and two boys (each block consist of 4 individuals), in random order. Then 11 blocks would be given carbamazepine and another 11 blocks would receive levetiracetam.
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 shiraz University of Medical Sciences
Street address
Zand St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2021-08-07, 1400/05/16
Ethics committee reference number
IR.SUMS.REC.1400.381
Health conditions studied
1
Description of health condition studied
patient diagnosed with Rolandic syndrome
ICD-10 code
G40.0
ICD-10 code description
Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
Primary outcomes
1
Description
rate of preventing epilepsy attacks
Timepoint
before the drug usage and 2 weeks, 1 and 3 months after the drug usage
Method of measurement
recording the number of epilepsy attacks viewed by family
What processes are involved for a request to access data/document
The applicant would be asked to provide a formal request letter containing the importance of the data and the project processes. Following the receipt of the request letter, the data would be provided maxim within 1 month.