Protocol summary
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Study aim
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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
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Design
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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 60 people.
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Settings and conduct
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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 20 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 40 mg/kg per day. Then it will continue with the same dose of medication. Patients will be examined at 4th, 12th , and 24th week.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention Group: Group receiving Levetiracetam
Control Group: Group receiving Carbamazepine
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Main outcome variables
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Seizure frequency and medicine's side effects
General information
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Reason for update
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The increase in the number of samples compared to the proposal, the amendment regarding the dosage of the drugs used in the study, and the amendment concerning the absence of any sponsors other than the Alborz University of Medical Sciences in this study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170216032603N2
Registration date:
2020-06-19, 1399/03/30
Registration timing:
registered_while_recruiting
Last update:
2025-01-02, 1403/10/13
Update count:
1
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Registration date
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2020-06-19, 1399/03/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-02, 1398/11/13
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Expected recruitment end date
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2021-03-02, 1399/12/12
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Analysis of the efficacy and side effects of Levetiracetam and Carbamazepine on treatment of children's epilepsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 2 years old to 14 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patients and the statistical analyzer were unaware of the drug used in each group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-02, 1398/11/13
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Ethics committee reference number
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IR.ABZUMS.REC.1398.208
Health conditions studied
1
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Description of health condition studied
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Partial Epilepsy
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ICD-10 code
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G40
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ICD-10 code description
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Epilepsy and recurrent seizures
Primary outcomes
1
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Description
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Medicine's Side Effects
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Timepoint
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Week 4, 12, 24 and if seizure or any side effects occur
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Method of measurement
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History and laboratory test result
Intervention groups
1
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Description
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Intervention group: The intervention group will be treated with Levetiracetam drug. The drug is started at a dose of 10 mg/kg per day and is increased by 10 mg/kg per week to reach the usual dose of 30 mg/kg per day. The maximum dose in these patients was 40 mg/kg. Then continue with the same dose.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group treated with Carbamazepine started with a dose of 5 mg/kg per day and increased by 5 kg/kg per week to reach the usual dose of 15 mg/kg. The maximum dose in these patients was 20 mg/kg. Then continue with the same dose.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Alborz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected information can be shared
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When the data will become available and for how long
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After the publication of results
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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Our data can be used with our permissions in academic classes
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From where data/document is obtainable
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Hadi Montazerlotfelahi with E-mail: h-mlotfelahi@razi.tums.ac.ir
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What processes are involved for a request to access data/document
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After a month we can share the data after complete understanding of aims
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Comments
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