Zonisamaide drug known as an anticonvulsant drug with a wide spectrum of function. Zonisamaide is effective in controlling of partial and generalized seizures.Pregabalin has anticonvulsant effect like Gabapentine. In previous studies what has been less evaluated is that these two drugs did not compared in view of their efficacy on pediatric interactable epilepsy. In this study ninty six children with seizures which admitted to Mofid Children Hospital and despite taking two or three anti-seizure medication, have uncontrolled seizure ,and have no neurodegenerative diseases has been randomly divided into two groups and the first group will be treated with Zonisamaide while the second group will be treated with Pregabalin and after one month and six months since drug starting reduction of the frequency and severity of seizures are analyzed. During the follow-up over fifty percent reduction in seizure frequency or severity is known as a response to drug .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091210508N4
Registration date:2012-10-20, 1391/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-20, 1391/07/29
Registrant information
Name
MohammadKazem Bakhshandeh Bali
Name of organization / entity
Shahid Beheshti medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 9625
Email address
dr.mk.bakhshandehbali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti Medical University
Expected recruitment start date
2012-04-01, 1391/01/13
Expected recruitment end date
2012-11-01, 1391/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisson of the effect of Zonisamide and Pregabalin as adjunctive therapy in control of interactable epilepsy in children
Public title
Effect of Zonisamide and Pregabalin in control of interactable epilepsy in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children one to eighteen years; having resistant epilepsy; referred to Mofid Children's Hospital
Exclusion criteria: children with neurodegenerative diseases
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak , Tehran
City
Tehran
Postal code
Approval date
2012-09-06, 1391/06/16
Ethics committee reference number
1391-1-146-1010
Health conditions studied
1
Description of health condition studied
Interactable epilepsy
ICD-10 code
G40
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Seizure
Timepoint
1 and 6 months later
Method of measurement
Interview
Secondary outcomes
empty
Intervention groups
1
Description
Ninety six children with seizures which admitted to Mofid children hospital and despite taking two or three anti-seizure medication, have uncontrolled seizure and have no neurodegenerative diseases has been randomly divided into two groups (1 and 2) and the group 1 will be treated with Zonisamaide oraly with dose of 2 - 12 miligram per kilogram daily and after one month and six months since drugs starting reduction of the frequency and severity of seizures are analyzed and compared with group 2. During the follow-up over fifty percent reduction in seizure frequency or severity is known as a response to drug .
Category
Treatment - Drugs
2
Description
Ninety six children with seizures which admitted to Mofid children hospital and despite taking two or three anti-seizure medication, have uncontrolled seizure and have no neurodegenerative diseases has been randomly divided into two groups (1 and 2) and the group 2 will be treated with Pregabalin oraly with dose of 5-15 miligram per kilogram daily and after one month and six months since drugs starting reduction of the frequency and severity of seizures are analyzed and compared with group 1. During the follow-up over fifty percent reduction in seizure frequency or severity is known as a response to drug .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology research center
Full name of responsible person
Dr Mohammad Kazem Bakhshandeh Bali
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr Ghofrani
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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
Pediatric neurology research center
Full name of responsible person
Dr Mohammad Kazem Bakhshandeh Bali
Position
Pediatric neurology fellow
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+212 2259625
Fax
Email
Dr.MK.Bakhshandehbali@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute of Child Neurology
Full name of responsible person
Dr Ghofrani
Position
Professor of Child Neurology
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+212 2259625
Fax
Email
Dr.MK.Bakhshandehbali@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric neurology research center
Full name of responsible person
Dr Mohammad Kazem Bakhshandeh Bali
Position
Pediatric neurology fellow
Other areas of specialty/work
Street address
No. 25 , Kamyar Lane , Shariati street , Tehran
City
Tehran
Postal code
Phone
+98 21 2225 9625
Fax
Email
Dr.MK.Bakhshandehbali@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)