This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
154
The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
Reduction during the Treatment Period in PGTC seizure frequency
Percentage reduction during the Treatment Period in seizure days
Responder rates in PGTC seizure frequency, and in seizure days of all types.
The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations
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