Comparison between the efficacy and side effects of Levetiracetam versus Carbamazepine as mono therapy in treatment of partial epilepsy of the children between 2 to 14 years old
Comparison between the efficacy and safety of “Levetiracetam” versus “Carbamazepine” as monotherapy in treatment of partial epilepsy of the children between 2 to 14 years old who referred to the Imam Ali hospital
Design
The study is a clinical trial, randomized, with intervention and control groups.
Based on previous studies, the sample size will be estimated according to the formula and the sample size ratio in each group will be 30 people.
Settings and conduct
It will take place in Imam Ali hospital as part of Alborz University of Medical Sciences in Iran. In this study, Levetiracetam and Carbamzepine will be randomly used for two groups. In the Carbamazepine group, the medicine will start with a dose of 5 mg/kg of body weight per day and increased by 5 mg/kg per week, and finally reaches the usual dose of 15 mg/kg per day. Then it will continue with the same dose. In the intervention group, the drug will start with a dose of 10 mg/kg per day and increased by 10 mg/kg per week to reach the usual dose of 30 mg/kg per day. Then it will continue with the same dose of medication. Patients will be examined at 4th, 12th , and 24th week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2 to 14 years old, partial epilepsy as a new case, informed consent of patients' parents, no history of renal and liver diseases
Exclusion criteria: History of seizure during the last 3 months, history of taking any anti-epileptic medicine, history of liver diseases , history of renal diseases, history of neurological disease under medical treatment
Intervention groups
Intervention Group: Group receiving Levetiracetam
Control Group: Group receiving Carbamazepine
Main outcome variables
Seizure frequency and medicine's side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170216032603N2
Registration date:2020-06-19, 1399/03/30
Registration timing:registered_while_recruiting
Last update:2020-06-19, 1399/03/30
Update count:1
Registration date
2020-06-19, 1399/03/30
Registrant information
Name
Hadi Montazer Lotf Elahi
Name of organization / entity
Tehran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 1493
Email address
h-mlotfelahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-02, 1398/11/13
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy and side effects of Levetiracetam versus Carbamazepine as mono therapy in treatment of partial epilepsy of the children between 2 to 14 years old
Public title
Analysis of the efficacy and side effects of Levetiracetam and Carbamazepine on treatment of children's epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2-14 years old
Partial epilepsy as a new onset
No history of renal disease
No history of liver disease
No history of cerebral palsy
Acceptance to be part of this study
Exclusion criteria:
Epilepsy in patients with any brain damage from three month ago
History of taking any anti-epileptic medications
History of liver disease
History of renal disease
History of neurological disease under medical treatment
Age
From 2 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients admitted or referred to the clinic will be divided into two groups based on the last digit of their file numbers. Patients with even last digit of file numbers will be in intervention group and patients will odd last digit of file numbers will be in control group. Intervention group will be treated by Levetiracetam and control group will be treated by Carbamazepine.
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 Alborz University of Medical Sciences
Street address
After University of Art, West Bu Ali St., Nabovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.ABZUMS.REC.1398.208
Health conditions studied
1
Description of health condition studied
Partial Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Medicine's Side Effects
Timepoint
Week 4, 12, 24 and if seizure or any side effects occur
Method of measurement
History and laboratory test result
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be treated with Levetiracetam under the brand name of Levebel, manufactured by Cobel Darou Company. The drug will start at a dose of 10 mg/kg twice a day and will increase to 10 mg/kg per week to reach a dose of 30 mg/kg per day. Then it will continue with the same dose.
Category
Treatment - Drugs
2
Description
Control group: the control group treatment will start with carbamazepine with a dose of 5 mg/kg twice daily and will increase by 5 kg/kg per week to a dose of 15 mg / kg. Then it will continue with the same dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Mrs Taftian
Street address
After University of Art, West Bu Ali St., Nabovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7483
Email
pezeshki@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Cobel Darou Co.
Street address
No. 39, Kambiz Alley, Alvand St., Arjantin Sq.
City
Tehran
Province
Tehran
Postal code
1389776363
Phone
+98 21 8867 1230
Email
info@cobeldarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hadi Montazer Lotfelahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
After University of Art, West Bu Ali St., Nabovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
hmontazer.hadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hadi Montazer Lotfelahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
After University of Art, West Bu Ali St., Nabovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
hmontazer.hadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hadi Montazer Lotfelahi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
After University of Art, West Bu Ali St., Nabovat Sq.
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7380
Email
hmontazer.hadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected information can be shared
When the data will become available and for how long
After the publication of results
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Our data can be used with our permissions in academic classes
From where data/document is obtainable
Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir
What processes are involved for a request to access data/document
After a month we can share the data after complete understanding of aims