levetiracetam versus carbamazepine monotherapy in the treatment of focal epilepsy of childre
Phase 3
- Conditions
- Epilepsy.Episodic diseases
- Registration Number
- IRCT2015030821355N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Children with age over one year and less than sixteen years old with newly diagnosed focal epilepsy, No history of refractory seizures, No history of renal disease, No history of hepatic disease, No history of cerebral palsy, No history of antiepileptic drug consumption.
Exclusion criteria: Pseudo- seizures, Skin rash especially Stevens Johnson syndrome, Drug-induced hepatitis, Acute psychosis, Renal disorders, Severe agitation, any other mild side effects that is unbearable to the patient or parents
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurence of seizure. Timepoint: Six months from the beginning of study. Method of measurement: Desciption of patients and parents.
- Secondary Outcome Measures
Name Time Method Rise of liver enzymes. Timepoint: One month after beginning of the study. Method of measurement: Measurment of AST and ALT.;Skin rash. Timepoint: In the six month from the beginning of the study. Method of measurement: Observation.;Agitation. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report.;Somnolence. Timepoint: In the six month from the beginning of the study. Method of measurement: Parents report.;Advers blood effects. Timepoint: One montn after beginning of study. Method of measurement: CBC examination.