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Clinical trial of evaluation of effectiveness and clinical side effects of levetiracetam and topiramate in control of seizures of oral prednisolone refractory infantile spasms

Protocol summary

Study aim
This study will be done to answer this question that whether or not levatiracetam is more efficient than topiramate in control of seizures of oral prednisolone refractory infantile spasms.
Design
single blinded parallel group clinical trial
Settings and conduct
،he drugs will be continued for three months and the children will be followed up monthly for three consecutive months.The trial uses computer generated equal simple randomization by random numbers and data collectors, outcome assessors and data analysts are kept blinded to the allocation.
Participants/Inclusion and exclusion criteria
sixty 2 months-1 year old infants with infantile spasms who would be referred to Pediatric Neurology Clinic of Shahid Sadoughi Hospital, Yazd, Iran that their seizures not controlled with 2 mg/kg/day oral prednisolone for one month , will be distributed randomly into two groups.
Intervention groups
In both groups to minimize side effects of drug, the dose will be increased in a weekly fashion to reach the maximum dose or the dose which controlled seizures in a four week period. In group I, levatiracetam will be started as a minimum of two divided doses and as follows: 10, 20, 30, 40 mg/kg/day. In group II, Topiramate will be started as a minimum of two divided doses and as follows: 3, 5, 7, 9 mg/kg/day. The drugs will be continued for three months and the children will be followed up monthly for three consecutive months.
Main outcome variables
Primary outcomes include daily frequency of seizure and treatment response that will be compared before and after three months of treatment. Secondary outcomes include more than 50% of reduction in daily frequency of seizure and clinical side effects.

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20091027002639N21
Registration date: 2018-09-22, 1397/06/31
Registration timing: registered_while_recruiting

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
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
Expected recruitment start date
2018-08-25, 1397/06/03
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation of effectiveness and clinical side effects of levetiracetam and topiramate in control of seizures of oral prednisolone refractory infantile spasms
Public title
Effect of levetiracetam and topiramate in infantile spasms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 2 months-1 year Having infantile spasms based on definition of the International League Against Epilepsy Resistance of their seizure to treatment of 2 mg/kg/day prednisolone for two months Not used of other antiepileptic drugs
Exclusion criteria:
Discontinuation of levetiracetam and topiramate usage for more than one week Allergy to levetiracetam and topiramate Irregular drugs usage Not returning for follow up
Age
From 2 months old to 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 30
sixty 2 months-1 year old infants with infantile spasms who would be referred to Pediatric Neurology Clinic of Shahid Sadoughi Hospital, Yazd, Iran that their seizures not controlled with 2 mg/kg/day oral prednisolone for one month , will be distributed randomly into two groupsُ
Randomization (investigator's opinion)
Randomized
Randomization description
Computer generated equal simple randomization by random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collectors, outcome assessors and data analysts are kept blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Central building of university, Bahonar square
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-08-25, 1397/06/03
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.085

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
Daily frequency of seizure
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient parents

2

Description
Treatment response
Timepoint
Before and after three months of treatment
Method of measurement
Asking from patient parents

Secondary outcomes

1

Description
Frequency of more than 50 % of reduction in daily frequency of seizure
Timepoint
Before and three months after treatment
Method of measurement
Asking from parents of patient

2

Description
Clinical side effects
Timepoint
During three months of treatment
Method of measurement
Asking from parents of patient

Intervention groups

1

Description
Intervention group1: Topiramate tablet of 25 or 50 mg from Darou Pakhsh Co, Iran with dosage of 3- 9mg/kg/day divided into two doses for three months
Category
Treatment - Drugs

2

Description
Intervention group2: Levebel syrup of 120 cc from Cobel Darou Co, Iran each milliliter contains 100 mg of levatiracetam per with dosage of 10- 40mg/kg/day divided into two doses for three months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Professor Razieh Fallah
Street address
Shahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887854
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
dr.raziehfallah@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mahmood Vakili
Street address
Central building of university, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887854
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
vakilim52@ssu.ac.ir
Web page address
Grant name
No
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Nahid Zareeian
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Shahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887854
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
zpneda@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Professor Razieh Fallah
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatric neurology
Street address
Shahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887854
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
dr.raziehfallah@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Professor Razieh Fallah
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric neurology
Street address
Shahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd
City
Yazd
Province
Yazd
Postal code
8915887854
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
dr.raziehfallah@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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