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Multicenter Trial for Adults With Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00034814
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:

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 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  (Clinical Trial)
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 : January 2002
Primary Completion Date : January 2006
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

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 [ Time Frame: 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 [ 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00034814     History of Changes
Other Study ID Numbers: IXL-201-14-189
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms