Pregabalin is one of the latest additions in the antiepileptic medications that are used in the treatment of refractory partial seizures in childhood. This 12-weeks, Open-labeled, before-after study is performed on children and adolescents under 18 years old age and evaluates the efficacy of pregabalin to reduce seizures frequency in these patients who suffering from refractory partial seizures. Exclusion criteria were included: current treatment with Vigabatrin or Felbamate; patients that having absence seizure, status epilepticus, Lennox syndrome and myoclonic seizure; renal failure; patients who suffering from neurometabolic or progressive neurologic disorders. Sample size based on statistical methods was about 30 patients. This study comprised three main phases; after selecting the patients and before the onset of the treatment period, in a period of 6 weeks (baseline phase), Average daily and weekly seizure of the patients were recorded by the patient, a trained observer or a legal guardian. After that, during a period of 2 weeks (dose-optimization phase), drug was started with a flexible dose of 25-75 mg/d TID or BID and then reached to maximum dose of 450 mg/d based on clinical response of the patient. In the next12 weeks (observation phase) the patients were given the drug and the average daily and weekly patient's seizures were recorded again. Responder rate and RRatio of the patients at the end of the study were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206099982N1
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Alireza Tavasoli
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2214 5982
Email address
a_tavasoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciensces ,Private Sector
Expected recruitment start date
2011-07-02, 1390/04/11
Expected recruitment end date
2011-09-02, 1390/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of pregabalin in the treatment of refractory partial seizures in children and adolescents under 18 years
Public title
Efficacy of pregabalin in control of seizures in children and adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
This study is performed on children and adolescents under 18 years old. Sexuality of the patient is not important for entrance to this study. Inclusion criteria are included: Patients aged under 18 years with a diagnosis of refractory partial seizures (namely if the seizure was not adequately controlled by one to three AEDs administered as monotherapy or in combination before entering the study); All patients with a minimum of 4-6 partial seizures in the baseline phase of the study; patient never had a maximum of 28 free seizure days in the baseline phase of the study.Exclusion criteria are included: current treatment with Vigabatrin or Felbamate; patients that having absence seizure, status epilepticus, Lennox syndrome and myoclonic seizure; renal failure; patients who suffering from neurometabolic or progressive neurologic disorders.
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:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science, Research deputy, Ethics Committee
Street address
Keshavarz blvd, next the ghods street, Tehran
City
Tehran
Postal code
Approval date
2012-07-14, 1391/04/24
Ethics committee reference number
130/801/ص/91
Health conditions studied
1
Description of health condition studied
Refractory epilepsy
ICD-10 code
G40.O,G40.
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Evaluation of efficacy of pregabalin in the treatment of refractory partial seizures in children and adolescents
Timepoint
At baseline period- At the end of treatment period
Method of measurement
RRatio(The mean seizure frequency in a 28 days period at the onset and end of the treatment period)
Secondary outcomes
1
Description
The percentage of patients who have not had a good clinical response; the percentage of the known complications of pregabalin among patients and determine the percentage of each side effects separately; determine the percentage of drug discontinuation among patients duo to side effects or ineffectiveness separately; the retention rate or number of patients who are still being received Pregabalin for part or all of the treatment period ; classification of seizure type in patients based on two groups: idiopathic and symptomatic
Timepoint
at the end of weeks:2,4,8,12 during treatment period
Method of measurement
weasured based on percentage
Intervention groups
1
Description
This 12-week, Open-labeled, before-after study comprised three main phases; after selecting the patients and before the onset of the treatment period, in a period of 6 weeks (baseline phase), Average daily and weekly seizure of the patients were recorded by the patient, a trained observer or a legal guardian. After that, during a period of 2 weeks (dose-optimization phase), drug was started with a flexible dose of 25-75 mg/d TID or BID and then reached to maximum dose of 450 mg/d based on clinical response of the patient.In the next12 weeks (observation phase) the patients were given the drug and the average daily and weekly patient's seizures were recorded again. Desired outcome of the study to decrease the seizure frequency of the patient by 50% compared to baseline period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Dr Alireza tavasoli, Dr Gholamreza zamani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Dr Alireza tavasoli, Dr Gholamreza zamani
Street address
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Children Medical Center
Full name of responsible person
Dr Alireza tavasoli
Position
Fellow of pediatric neurology
Other areas of specialty/work
Street address
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
dralit73@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children Medical Center
Full name of responsible person
Dr Gholamreza zamani
Position
Pediatric Neurologist
Other areas of specialty/work
Street address
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
ghrzamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children Medical Center
Full name of responsible person
Dr Alireza tavasoli
Position
Fellow of pediatric neurology
Other areas of specialty/work
Street address
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
Email
dralit73@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)