Comparative study of the clinical effect and side effects of lacosamide and sodium valproate in reducing and controlling seizures in generalized seizures during six months
Comparative study of the clinical effect and side effects of lacosamide and sodium valproate in reducing and controlling seizures in generalized seizures during six months
Design
This study is an unblinded clinical trial method. 120 eligible patients are randomly assigned to two intervention groups. The first group is treated with lacosamide and the second group is treated with sodium valproate, and the patients are examined for the number of seizures and brain scans and side effects.
Settings and conduct
Patients referred to Shahid Beheshti Hospital of Qom with generalized tonic colonic seizures are divided into two groups using block randomization method. The first group is treated with lacosamide with a dose of 200 mg twice a day, and the second group is treated with sodium valproate 500 mg twice a day, and the patients of both groups are treated daily before the start of treatment and three months after the start. The treatment and six months after the start of the treatment are checked in terms of reduction or complete control of seizure attacks and brain scan findings (in terms of presence of seizure waves) and drug side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Seizures in general tonic clonic; over eighteen years of age; consent to participate in the study; Not taking multiple anticonvulsants at the same time
Exclusion criteria: Patients' willingness to withdraw from the study; any condition that makes follow-up of patients impossible; Having a chronic disease that impairs the patient's evaluation; suffering from heart diseases; pregnancy
Intervention groups
In the intervention group, lacosamide is administered orally at a dose of 200 mg twice a day, and in the control group, sodium valproate is administered orally at a dose of 500 mg twice a day.
Main outcome variables
Control of generalized seizures.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220524054982N1
Registration date:2022-11-06, 1401/08/15
Registration timing:prospective
Last update:2022-11-06, 1401/08/15
Update count:0
Registration date
2022-11-06, 1401/08/15
Registrant information
Name
Payam Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3322 2023
Email address
molavi.payam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the clinical effect and side effects of lacosamide and sodium valproate in reducing and controlling seizures in generalized seizures during six months
Public title
Investigation of the effectiveness of lacosamide in generalized seizures.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having generalized tonic-clonic seizures
Over eighteen years of age
Consent to participate in the study
Not taking multiple anticonvulsants at the same time
Exclusion criteria:
Willingness of patients to withdraw from the study
-
Having a chronic disease that interferes with the evaluation of the patient
Having heart diseases
pregnancy
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done (blocks 4 and 6). Proprietary sequences and secret codes are generated using www.sealedenvelope.com.
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
Qom University of Medical Sciences and Health Services
Street address
Qom Province, Qom, Shahid Lavasani St, MV2R+P89
City
Qom
Province
Ghoum
Postal code
3736175513
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.MUQ.REC.1401.004
Health conditions studied
1
Description of health condition studied
Generalized tonic-clonic seizures.
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
tonic-clonic seizure
Timepoint
On the first day and three months later and six months after starting the drug
Method of measurement
EEG device and patient bedside
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, lacosamide is used orally and monotherapy at a dose of 200 mg twice a day (any brand). Patients are followed up for six months and checked for the number of seizures.
Category
Treatment - Drugs
2
Description
In the control group, the drug sodium valproate with a dose of 500 mg twice a day is used orally and monotherapy. Patients are followed up for six months and checked for the number of seizures.
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
In this study, statistical data (mean, minimum and maximum) of demographic variables of all samples and not individually studied can be published and the results of drug effectiveness after data analysis can be published without mentioning the names and details of individuals
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
All scientific and academic researchers with mentioning the name and scientific affiliation
Under which criteria data/document could be used
Using the method of studying and analyzing data and results with the permission of the authors or scientific citations in journals, articles and sources is allowed.
From where data/document is obtainable
To the corresponding author whose email details were given and also specified in the relevant articles
What processes are involved for a request to access data/document
The request will be sent by email. After consulting with the other authors and agreeing to sponsor the project, the information that can be published will be made available to another person or organization