Efficacy of pregabalin in control of seizures in children and adolescents
- Conditions
- Refractory epilepsy.Episodic and paroxysmal disordersG40.O,G40.
- Registration Number
- IRCT201206099982N1
- Lead Sponsor
- Private
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 26
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.