A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
DOUBLE
Enrollment
580
To demonstrate that levetiracetam monotherapy is not inferior to carbamazepine by measuring the proportion of subjects with 6-month seizure freedom in subjects newly diagnosed as suffering from epilepsy.
Proportion of subjects with one year seizure freedom; time to first seizure; safety.
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