Refractory epilepsy. Episodic and paroxysmal disorders
Conditions
Interventions
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 tra
Treatment - Drugs
Sponsors
Private
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Alireza tavasoli
Children Medical Center
Outcome results
None listed