Protocol summary

Summary
Objectives: To assess the effect of sodium valproate, levetiracetam, and lamotrigine on seizure attacks and EEG disorders in patients with juvenile myoclonic epilepsy. Design: a double blind randomized clinical trial. Setting and conduct: The eligible patients with juvenile myoclonic epilepsy who will refer to Imam Khomeini Clinic during the study period will be enrolled into the trial. Inclusion criteria: affected with juvenile myoclonic epilepsy; age of over 12 years. Exclusion criteria: having severe organic diseases, heart failure, liver disorder, renal disease, or electrolyte disorder; abnormal MRI image; mental retardation; pregnancy or breastfeeding; alcohol or drug dependence; needing to more than one drug for controlling seizure; noncompliance. Intervention group 1: oral levetiracetam 500 mg twice a day for 6 months. Intervention group 2: oral lamotrigine 100 mg twice a day for 6 months. Control group: Oral sodium valproate 500 mg once a day for 6 months. Primary outcome: Assessing seizure attacks before intervention, and 1, 2, and 6 months after intervention through history taking. Secondary outcome: Assessing EEG disorders before intervention, and 1, 2, and 6 months after intervention using electroencephalogram. Randomization: Random assignment of the patients to the intervention and control groups one at a time. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509079014N79
Registration date: 2015-09-18, 1394/06/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-18, 1394/06/27
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
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sodium valproate, levetiracetam, and lamotrigine on seizure attacks and EEG disorders in patients with juvenile myoclonic epilepsy: a double blind randomized clinical trial
Public title
Comparison of the effect of sodium valproate, levetiracetam, and lamotrigine on seizure attacks and EEG disorders in patients with juvenile myoclonic epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: affected with juvenile myoclonic epilepsy; age of over 12 years. Exclusion criteria: having severe organic diseases, heart failure, liver disorder, renal disease, or electrolyte disorder; abnormal MRI image; mental retardation; pregnancy or breastfeeding; alcohol or drug dependence; needing to more than one drug for controlling seizure; noncompliance.
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.

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 the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.UMSHA.REC.1394.71

Health conditions studied

1

Description of health condition studied
juvenile myoclonic epilepsy
ICD-10 code
G40.3
ICD-10 code description
Generalized idiopathic epilepsy and epileptic syndromes

Primary outcomes

1

Description
Assessing seizure attacks
Timepoint
before intervention, and 1, 2, and 6 months after intervention
Method of measurement
through history taking

Secondary outcomes

1

Description
Assessing EEG disorders
Timepoint
before intervention, and 1, 2, and 6 months after intervention
Method of measurement
using electroencephalogram

Intervention groups

1

Description
oral levetiracetam 500 mg twice a day for 6 months
Category
Treatment - Drugs

2

Description
oral lamotrigine 100 mg twice a day for 6 months.
Category
Treatment - Drugs

3

Description
oral sodium valproate 500 mg once a day for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Dr Sahar Moradi
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Sahar Moradi
Position
Resident of Neurology
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3388 0572
Fax
Email
sahar.moradi33@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Masoud Ghiasian
Position
Neurologist
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3388 0572
Fax
Email
masoud_ghiasian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Fax
Email
poorolajal@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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