The aim of this study is to compare the monotherapy effect of levetiracetam with carbamazepine in the treatment of children with focal epilepsy. For this purpose, children with age over one year and less than sixteen years old with newly diagnosed focal epilepsy, are entered to study. This is a randomized prospective study. Patients with Pseudo- seizures; Skin rash especially Stevens Johnson syndrome; Drug-induced hepatitis; Acute psychosis; Renal disorders; Severe agitation, are excluded from the study. The children are randomly treated by Levetiracetam or Carbamazepine. All patients are followed for the occurrence of seizures and side effects in one and six-month intervals. For investigation of side effects, liver function tests and complete blood count is done for all patients. For other considerable side effects such as drowsiness, restlessness and skin complications, patients are questioned.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030821355N1
Registration date:2017-01-12, 1395/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Hosein Eslamiyeh
Name of organization / entity
Shahid Sadoughi University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 353724015
Email address
eslamieh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-07-02, 1393/04/11
Expected recruitment end date
2015-03-05, 1393/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children
Public title
levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children with age over one year and less than sixteen years old with newly diagnosed focal epilepsy, No history of refractory seizures, No history of renal disease, No history of hepatic disease, No history of cerebral palsy, No history of antiepileptic drug consumption.
Exclusion criteria: Pseudo- seizures, Skin rash especially Stevens Johnson syndrome, Drug-induced hepatitis, Acute psychosis, Renal disorders, Severe agitation, any other mild side effects that is unbearable to the patient or parents
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ehics comittee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vakil abad
City
Mashhad
Postal code
9177948976
Approval date
2013-12-03, 1392/09/12
Ethics committee reference number
t-3181
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Episodic diseases
Primary outcomes
1
Description
Occurence of seizure
Timepoint
Six months from the beginning of study
Method of measurement
Desciption of patients and parents
Secondary outcomes
1
Description
Rise of liver enzymes
Timepoint
One month after beginning of the study
Method of measurement
Measurment of AST and ALT
2
Description
Skin rash
Timepoint
In the six month from the beginning of the study
Method of measurement
Observation
3
Description
Agitation
Timepoint
In the six month from the beginning of the study
Method of measurement
Parents report
4
Description
Somnolence
Timepoint
In the six month from the beginning of the study
Method of measurement
Parents report
5
Description
Advers blood effects
Timepoint
One montn after beginning of study
Method of measurement
CBC examination
Intervention groups
1
Description
Control Group: carbamazepine group: This group will be treated with carbamazepine. In carbamazepine group,the drug with the dose of 5 mg/kg/day is initiated and increases 5 mg/kg/week. finlay, it reaches to the current dose of 15 mg/kg/per day. Then, with the same dose, the drug continues.
Category
Treatment - Drugs
2
Description
Intervention Group: levetiracetam group: This group will be treated with levetiracetam. In levetiracetam group,the drug with the dose of10 mg/kg per day is initiated and increases 10 mg/kg/week . finlay, it reaches to the current dose of30 mg/kg/per day. Then, with the same dose, the drug continues.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Hosein Eslamiyeh
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Eslamiyeh
Street address
Ghaem hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Eslamiyeh
Position
Assistant professor, pediatric neurologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
Eslamieh@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem hospital
Full name of responsible person
Hosein Eslamiyeh
Position
Peditric neurologist. Assistant professor
Other areas of specialty/work
Street address
Ghaem hospital, Ahmad abad
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
Eslamieh@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem hospital
Full name of responsible person
Hosein Eslamiyeh
Position
Peditric neurologist. Assistant professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Yazd
City
Yazd
Postal code
8915887857
Phone
+98 35 3822 9104
Fax
+98 35 3822 9104
Email
eslamieh@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)