To assess the effect of levetiracetam monotherapy versus sodium valproate on the treatment of children with generalized or focal epilepsy
Design
This is a randomized clinical trial, phase II, in which 44 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible children with generalized or focal epilepsy referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 2 to 18 years,
Generalized or focal epilepsy,
Exclusion criteria:
False seizures,
Sustained brain injury,
Acute psychosis,
History of cerebral palsy,
Pharmaceutic hepatitis,
Liver disease,
Kidney disease
Intervention groups
Intervention group:
Levetiracetam syrup (manufactured by Lubel Daru Pharmaceutical Co.) 30 mg/kg every 12 hours for 18 months
Control group:
Sodium valproate syrup (manufactured by Razak Pharmaceutical Co.) 30-30 mg/kg every 12 hours for 18 months
Main outcome variables
Primary outcome:
Number of seizures
Secondary outcome:
Blood complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N351
Registration date:2020-04-04, 1399/01/16
Registration timing:registered_while_recruiting
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of levetiracetam monotherapy versus sodium valproate on treatment of children with generalized or focal epilepsy: a randomized clinical trial
Public title
Effect of levetiracetam monotherapy versus sodium valproate on treatment of children with generalized or focal epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 2 to 18 years,
Generalized or focal epilepsy,
Exclusion criteria:
False seizures,
Sustained brain injury,
Acute psychosis,
History of cerebral palsy,
Pharmaceutic hepatitis,
Liver disease,
Kidney disease
Age
From 2 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.UMSHA.REC.1398.338
Health conditions studied
1
Description of health condition studied
Focal epilepsy
ICD-10 code
G40.0
ICD-10 code description
Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
2
Description of health condition studied
Generalized epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes
Primary outcomes
1
Description
Number of seizures
Timepoint
Every month
Method of measurement
By taking history
Secondary outcomes
1
Description
Blood complications
Timepoint
One month after the intervention
Method of measurement
By checking cell blood count
Intervention groups
1
Description
Intervention group: Levetiracetam syrup (manufactured by Lubel Daru Pharmaceutical Co.) 30 mg/kg every 12 hours for 18 months
Category
Treatment - Drugs
2
Description
Control group: Sodium valproate syrup (manufactured by Razak Pharmaceutical Co.) 30-30 mg/kg every 12 hours for 18 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Ghazal Sami
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
drsami.pediatrician@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ghazal Sami
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drsami.pediatrician@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Afshin Fayyazi
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
afshin.fayyazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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