NCT00034814

Multicenter Trial for Adults With Partial Seizures

Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Talampanel	Non-enzyme-inducing TLP 35mg TID
DRUG	Placebo	Enzyme-inducing placebo TID
DRUG	Talampanel	Enzyme-inducing Talampanel 35 mg TID
DRUG	Talampanel	Enzyme-inducing TLP 50mg TID
DRUG	Placebo	Non-enzyme-inducing placebo TID
DRUG	Talampanel	Non-enzyme-inducing TLP 25mg TID

Timeline

• Start date: 2002-01-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2002-05-03
• Last updated: 2011-03-17