Infantile spasms are poor prognosis epileptic syndrome. The purpose of this study was to compare clinical efficacy and safety of Topiramate and Nitrazepam in the treatment of infantile spasm. In a randomized clinical trial, 50 children with infantile spasms, aged 2 months to 2 years who are not receiving anticonvulsant treatment will be assigned to receive either Topiramate, 3-12 mg/kg/day or Nitrazepam, 0.5-1 mg/kg/day for two months. Frequency of seizure attacks and adverse effects will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808052639N1
Registration date:2009-12-12, 1388/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-12-12, 1388/09/21
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Sadoughi University of Medical Sciences, Yazd
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Topiramate and Nitrazepam in infantile spasms treatment
Public title
Comparison of efficacy of Topiramate and Nitrazepam in infantile spasms treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Age range : 2 months to 2 years, presence of infantile spasms ,
Exclusion criteria : Low compliance, hard to follow up, recieving anticonvulsant drugs
Age
To 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Faculty of Medicine ethics committee, Shaheed Sadoughi Universuty of Medical Sciences,
Street address
Boo ali street, Safaeeh, Yazd
City
Yazd
Postal code
Approval date
2009-10-10, 1388/07/18
Ethics committee reference number
65767/1/17/پ
Health conditions studied
1
Description of health condition studied
Infantile spasms
ICD-10 code
G40.4
ICD-10 code description
Other generalized epilepsy and epileptic syndromes
Primary outcomes
1
Description
Monthly freuency of seizures
Timepoint
Two months before intervention, one and two months after intervention
Method of measurement
Recording seizure attacks by parents
Secondary outcomes
1
Description
side effects
Timepoint
Every month during the study period
Method of measurement
Recording seizure attacks by parents
Intervention groups
1
Description
Topiramate, oral, 3-12 mg/kg/day for two months
Category
Treatment - Drugs
2
Description
Nitrazepam, oral, 0.5-1 mg/kg/day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric neurology clinic of Shaheed Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Razieh Fallah
Street address
Taleghani Blvd, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ezoddine
Street address
Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed Sadoughi 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Razieh Fallah
Position
Assistant Professor, Pediatric Neurologist
Other areas of specialty/work
Street address
Shaheed Sadoughi Hospital, Pediatrics Ward
City
Yazd
Postal code
Phone
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)