Multicenter Trial for Adults With Partial Seizures
- Registration Number
- NCT00034814
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3 Talampanel Enzyme-inducing TLP 50mg TID 6 Talampanel Non-enzyme-inducing TLP 35mg TID 1 Placebo Enzyme-inducing placebo TID 2 Talampanel Enzyme-inducing Talampanel 35 mg TID 4 Placebo Non-enzyme-inducing placebo TID 5 Talampanel Non-enzyme-inducing TLP 25mg TID
- Primary Outcome Measures
Name Time Method Reduction in frequency of partial seizures 12 weeks Change in frequency of recognizable seizures as measured by entries in a seizure diary
- Secondary Outcome Measures
Name Time Method 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