determining the effect of Lacosamide on reducing interictal epileptiform discharges on children with epilepsy
Design
In all patients participating in the study, Lacosamide will be added to their previous drugs (the EEG before and after taking the drug is compared and we do not have a control group).
Settings and conduct
we add Lacosamide ( lacosa) to their previous drugs with an initial dose of 2mg/kg, which is increased to a dose of 8mg/kg within 4 weeks.
EEG will be repeated for all children before starting treatment with lacosamide and 1 month after starting treatment.
. EEG is taken for 20 minutes and the intensity of epileptic waves including the number of epileptic waves in waves per minute and the duration of epileptic waves will be calculated to the total time of EEG. EEG will be taken and interpreted by an expert and blind. The number of seizure recurrences in a month will be collected in the prepared checklist. Observed complications are recorded. The possible side effects of the drug, which are based on the drug brochure, such as dizziness, tingling in the legs, blurred vision, nausea, vomiting, drowsiness, loss of balance, and memory problems, will be recorded for each participant.
Participants/Inclusion and exclusion criteria
Children with idiopathic or symptomatic epilepsy with an age range of 4 to 15 years
The presence of epileptic waves in at least 50% of the initial EEG
Intervention groups
For all eligible patients (4 to 15-year-old children with epilepsy who have epileptic waves in at least 50% of the initial EEG), lacosamide tablets (lacsa) are prescribed in addition to the drugs they were already taking.
EEG will be repeated for all children before starting treatment with lacosamide and 1 month after starting treatment.
Main outcome variables
using Lacosamide to decrease interictal epileptiform discharges in children with epilepsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120821010634N5
Registration date:2025-03-21, 1404/01/01
Registration timing:registered_while_recruiting
Last update:2025-03-21, 1404/01/01
Update count:0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Afshin Fayazi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0075
Email address
afshin_fay@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-04, 1403/08/14
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Lacosamide on EEG Interictal Epileptiform Discharges of Children with Epilepsy.
Public title
The Effect of Lacosamide on EEG Interictal Epileptiform Discharges of Children with Epilepsy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with idiopathic or symptomatic epilepsy with an age range of 4 to 15 years
The presence of epileptic waves in at least 50% of the initial EEG
Exclusion criteria:
Children younger than 4 years old or older than 15 years old
Children with absence or similar epilepsy in which there are contraindications for taking drugs like lacosamide.
Age
From 4 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Deputy of research, Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2024-11-03, 1403/08/13
Ethics committee reference number
IR.UMSHA.REC.1403.551
Health conditions studied
1
Description of health condition studied
Effect of Lacosamide on EEG of Children with Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
number of epileptiform discharges on EEG
Timepoint
before starting the trial and 1 month after that
Method of measurement
Electrophysiological data will be collected by an EEG data recorder (24-channel Ebenevo device).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All people participating in the trial will be given lacosamide drug, and before receiving the drug and one month after that, an EEG will be taken from them, and the number of epileptiform discharges in these two EEGs will be compared.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Fayazi's Pediatric Neurology Office
Full name of responsible person
Afshin Fayazi
Street address
Parvin Etisami 2 Alley, Mirzadeh Eshghi St.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3826 5630
Email
Afshin_Fay@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Khazayi
Street address
Hamedan University of Medical Science, Shahid Fahmideh.St.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 2112
Email
Afshin_Fay@yahoo.com
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
Afshin Fayazi
Position
consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1796
Fax
Email
Afshin_Fay@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Fayazi
Position
consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 1264 0075
Fax
+98 81 1264 0075
Email
afshin_fay@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Fayazi
Position
consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., pajoohesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3826 5630
Email
Afshin_Fay@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
General information including the age and gender of people in the participating groups and the factors affecting the effectiveness of the drug will be published, and other information will be provided to other researchers at the discretion of the person in charge of the research and after reviewing the requests one by one.
When the data will become available and for how long
It will be possible to access the information from 1403 until two years after the publication of the results
To whom data/document is available
Researchers who want to do additional research in this field.
Under which criteria data/document could be used
The data published in the article will be available to the public at the discretion of the journal. Other information will be available to the researcher at the discretion of the professor in charge of the research and after reviewing the requests one by one.
From where data/document is obtainable
Refer to the professor in charge of the research.
What processes are involved for a request to access data/document
An e-mail will be sent to the professor in charge of the research, and the information file will be provided to the researcher if the relevant professor decides.