Comparison of therapeutic effect and monotherapy with lacosamide against carbamazepine in children with newly diagnosed epilepsy
Design
Clinical trial with 2 parallel groups, open-label, randomized, phase 3 on 100 patients. The random allocate software was used for randomization.
Settings and conduct
Children with newly diagnosed epilepsy who are hospitalized in Bu Ali Sina Hospital will be randomly divided into two groups A and B. Group A will receive lacosamide and group B will receive carbamazepine. Demographic information and clinical conditions of the patients will be recorded before entering the study, and then in the follow-up visits every three months, the two groups will be compared with each other in terms of recovery and complications.
Participants/Inclusion and exclusion criteria
The inclusion criteria of the study are children between the ages of 4 and 16 who have newly been diagnosed with epilepsy.
exclusion criteria:
1. History of liver disease or heart disease
2. Receiving anti-seizure medication for more than 48 hours during the last three months
3. Patients with any neurodegenerative or neurometabolic disease
4. history of hypersensitivity reaction
5. Lack of consent of the patient and the patient's guardian
6. Patients with a history of bone marrow suppression
Intervention groups
Group A: Lacosamide
Group B: carbamazepine
Main outcome variables
Primary outcome: at least a 6-month seizure-free period.
Secondary outcome: drug side effects (aplastic anemia - agranulocytosis - liver dysfunction (increase of AST, ALT above 5 times the normal range) - hyponatremia (Na less than 135).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231123060147N1
Registration date:2024-01-12, 1402/10/22
Registration timing:registered_while_recruiting
Last update:2024-01-12, 1402/10/22
Update count:0
Registration date
2024-01-12, 1402/10/22
Registrant information
Name
Paniz Balmeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 1367
Email address
alipourvavsari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-10, 1402/09/19
Expected recruitment end date
2024-02-08, 1402/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects and monotherapy with lacosamide versus carbamazepine in children with newly diagnosed epilepsy
Public title
Investigation of therapeutic effect and monotherapy with lacosamide compared to carbamazepine in children with epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged between 4 and 16 years with newly diagnosed epilepsy
Exclusion criteria:
History of liver disease and history of heart disease
Receiving antiepileptic medication for more than 48 hours during the last three months
Patients with any neurodegenerative or neurometabolic disease
causing an allergic reaction
Dissatisfaction of the patient and the patient's parents
Patients with a history of bone marrow suppression
Age
From 4 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding in this study will be as follows, so that at the beginning of the study, an envelope that has only one code on it is randomly given to them, and the type of treatment group is determined in the envelope, and the envelope is opened by the pharmacy and the drug is already It will be prepared and delivered to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mazandaran University of Medical Sciences
Street address
Sari, Imam Square, Serah Joibar, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2023-10-24, 1402/08/02
Ethics committee reference number
IR.MAZUMS.REC.1402.466
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
At least a period of 6 months without seizures
Timepoint
For 6 months, the number and type of seizures experienced by the child from the previous visit will be asked
Method of measurement
Observing types of seizures by parents
Secondary outcomes
1
Description
Drug side effects includes (aplastic anemia - agranulocytosis - liver disorder (increased AST, ALT more than 5 times the normal range) - hyponatremia (Na less than 135).
Timepoint
6 months after drug intervention
Method of measurement
Observation of drug complications includes (aplastic anemia - agranulocytosis - liver dysfunction (increase of AST, ALT above 5 times the normal range) - hyponatremia (Na less than 135).
Intervention groups
1
Description
Intervention group: Lacosamide (Unimide brand) was started with a daily dose of 2 mg/kg/day divided into two doses (BD) and continued with an increase of 2 mg/kg/day every week to a maximum dose of 10 mg/kg/day if tolerated.
Category
Treatment - Drugs
2
Description
Intervention group: Carbamazepine (brand name Tegatard) with a dose of 5 mg/kg/day (BD) during the first week and with an increase of 5 mg/kg/day every week to a maximum dose of 20 mg/kg/day if tolerated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Kobra Sheidaee
Street address
Mazandaran, Sari, Pasdaran Blvd., Bo Ali Sina Medical Education Center
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
user.k.s4834@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Mazandaran Province, Sari City, Moalem Square, Research and Technology Deputy Building
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Kobra Sheidaee
Position
Assistant Professor of Pediatric Neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Sari, Imam Square, Serah Joibar, the beginning of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
user.k.s4834@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kobra Sheidaee
Position
Assistant Professor of Pediatric Neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Sari, Imam Square, Serah Joibar, the beginning of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
user.k.s4834@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Kobra Sheidaee
Position
Assistant Professor of Pediatric Neurology
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Sari, Imam Square, Serah Joibar, the beginning of Valiasr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
user.k.s4834@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information There is no more information