Seizure is very important in chilhood age. Prevalence of seizure is about 0/5 to 1 persent.About 25% of these patients dont responce to tretments and known as refractory seizures.There are many drugs for epilepsy .Some of them cure and some reduce the frequency or intensity of seizures.Pregabalin is a new antiepileptic drug . There are a few study with PGB in children. In this study we prescribed PGB in refractory childhood epilepsy.
General information
Acronym
pregabalin:PGB
IRCT registration information
IRCT registration number:IRCT2014012216320N1
Registration date:2014-05-23, 1393/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Mohsen Mollamohammadi
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3260 3518
Email address
dr.mmohamadi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom university of medical science
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
pregabalin in childhood epilepsy: clinical trial in qom and tehran
Public title
pregabalin in childhood eoilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critria: all patients with refractory seizure
Exclusion criteria: patients with myoclonic siezures; sensitivty to PGB; patients that recieved gabapentin.
Age
From 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom university of medical science
Street address
Shahid lavasany ave. qom
City
Qom
Postal code
371697115
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
MUQ.REC.1393.4
Health conditions studied
1
Description of health condition studied
Seizure
ICD-10 code
G40
ICD-10 code description
Attack with loss of consciousness
Primary outcomes
1
Description
Decrease count of seizure
Timepoint
One and four mounth after intervention
Method of measurement
Counting
2
Description
Decrease intensity of seizure
Timepoint
One and four month after intervention
Method of measurement
Asking from parents
Secondary outcomes
1
Description
Drug reaction
Timepoint
One and four month after interventionque
Method of measurement
Quetionair
Intervention groups
1
Description
Pregabalin used as add on therapy in childhood epilepsy.cap.25-50-75-100-150 mg.10mg/kg/day.2-3 time/day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat masomeh hospital-Qom
Full name of responsible person
Dr. molla mohammadi
Street address
Emam khomeiny ave.
City
Qom
2
Recruitment center
Name of recruitment center
Mofid hospital--Tehran
Full name of responsible person
Dr.mohsen molla mohammadi
Street address
Shariati street.tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr. Hosein Saghafi
Street address
No 83, No 4 ave, No 1.1 ave, Safa Shahr. Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom medical university
Full name of responsible person
Mohsen molla mohammadi
Position
Assistant profesor-pediatric neurologist
Other areas of specialty/work
Street address
Qom.hazrat masoumeh hospital
City
Qom
Postal code
Phone
+98 25 3665 1802
Fax
Email
dr.mmohamadi@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hasan Tonekabony
Position
Professor
Other areas of specialty/work
Street address
Mofid hospital, Shariati street,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2241 3017
Fax
Email
sh.tonekabony@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom medical university
Full name of responsible person
Mohsem molla mohammadi
Position
Assistant profesor
Other areas of specialty/work
Street address
Hazrat masoumeh hospital-qom
City
Qom
Postal code
3719815539
Phone
+98 25 3665 1802
Fax
Email
dr.mmohamadi@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)