Investigation of therapeutic effect and monotherapy with lacosamide compared to carbamazepine in children with epilepsy
Phase 3
Recruiting
- Conditions
- Epilepsy.Epilepsy and recurrent seizures
- Registration Number
- IRCT20231123060147N1
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Children aged between 4 and 16 years with newly diagnosed epilepsy
Exclusion Criteria
History of liver disease and history of heart disease
Receiving antiepileptic medication for more than 48 hours during the last three months
Patients with any neurodegenerative or neurometabolic disease
causing an allergic reaction
Dissatisfaction of the patient and the patient's parents
Patients with a history of bone marrow suppression
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At least a period of 6 months without seizures. Timepoint: For 6 months, the number and type of seizures experienced by the child from the previous visit will be asked. Method of measurement: Observing types of seizures by parents.
- Secondary Outcome Measures
Name Time Method Drug side effects includes (aplastic anemia - agranulocytosis - liver disorder (increased AST, ALT more than 5 times the normal range) - hyponatremia (Na less than 135). Timepoint: 6 months after drug intervention. Method of measurement: Observation of drug complications includes (aplastic anemia - agranulocytosis - liver dysfunction (increase of AST, ALT above 5 times the normal range) - hyponatremia (Na less than 135).