Multicenter Trial for Adults With Partial Seizures

March 15, 2011 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in frequency of partial seizures
Time Frame: 12 weeks
Change in frequency of recognizable seizures as measured by entries in a seizure diary
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of seizure-free days and percent responders
Time Frame: 12 weeks
A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXL-201-14-189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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