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IRCT201206099982N1 IRCT 2012-08-09 Private Efficacy of pregabalin in control of seizures in children and adolescents Evaluation of efficacy of pregabalin in the treatment of refractory partial seizures in children and adolescents under 18 years 2011-07-02 anticipated 26 Complete https://irct.ir/trial/10489 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Refractory epilepsy. 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..
public Dr Alireza tavasoli
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 5848 dralit73@yahoo.com Children Medical Center scientific Dr Gholamreza zamani
Pediatric neurology ward, Children medical center, Gharib Avenue, Keshavarz blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 5848 ghrzamani@yahoo.com Children Medical Center Iran (Islamic Republic of) 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. 1 year 18 years Both G40.O,G40. Episodic and paroxysmal disorders Treatment - Drugs 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. 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). 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. Private Approved 2012-07-14 Tehran University of Medical Science, Research deputy, Ethics Committee Keshavarz blvd, next the ghods street, Tehran Tehran Iran (Islamic Republic of)