Epilepsy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTalampanel
Non-enzyme-inducing TLP 35mg TID
DRUGPlacebo
Enzyme-inducing placebo TID
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* must weigh greater than or equal to 40kg * Patients must have diagnosis of partial seizures * At least 3 observable partial seizures a month * Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs. Exclusion: * Patients on Valproic acid, and Felbamate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in frequency of partial seizures | 12 weeks | Change in frequency of recognizable seizures as measured by entries in a seizure diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of seizure-free days and percent responders | 12 weeks | A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline |
Outcome results
None listed