Multicenter Trial for Adults With Partial Seizures

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00034814
• Collaborator: (none)
• Enrollment: 190
• Arms: 6
• Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Talampanel; Drug: Placebo; Drug: Talampanel; Drug: Talampanel; Drug: Placebo; Drug: Talampanel	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Enzyme-inducing placebo TID	Drug: Placebo; Enzyme-inducing placebo TID
Experimental: 2 Enzyme-inducing Talampanel 35 mg TID	Drug: Talampanel; Enzyme-inducing Talampanel 35 mg TID
Experimental: 3 Enzyme-inducing TLP 50mg TID	Drug: Talampanel; Enzyme-inducing TLP 50mg TID
Placebo Comparator: 4 Non-enzyme-inducing placebo TID	Drug: Placebo; Non-enzyme-inducing placebo TID
Experimental: 5 Non-enzyme-inducing TLP 25mg TID	Drug: Talampanel; Non-enzyme-inducing TLP 25mg TID
Experimental: 6 Non-enzyme-inducing TLP 35mg TID	Drug: Talampanel; Non-enzyme-inducing TLP 35mg TID

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00034814
• Other Study ID Numbers: IXL-201-14-189
• First Posted: May 3, 2002
• Last Update Posted: Mar 17, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Seizures

Study Results

No Results Posted as of Mar 17, 2011