To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.
A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
190
Non-enzyme-inducing TLP 35mg TID
Enzyme-inducing placebo TID
Enzyme-inducing Talampanel 35 mg TID
Reduction in frequency of partial seizures
Change in frequency of recognizable seizures as measured by entries in a seizure diary
Time frame: 12 weeks
The number of seizure-free days and percent responders
A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline
Time frame: 12 weeks
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Enzyme-inducing TLP 50mg TID
Non-enzyme-inducing placebo TID
Non-enzyme-inducing TLP 25mg TID