Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Epilepsy
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate
Eligibility Criteria
Inclusion Criteria: Diagnosis of epilepsy (all types of seizures) was made during the past year Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method Exclusion Criteria: Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial Pregnant or lactating women Presence of known pseudoseizures within the last year Uncountable seizures (clusters) or history of convulsive status epilepticus Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Levetiracetam
Older Antepileptic Drugs
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.