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Multicenter Trial for Adults With Partial Seizures

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00034814
First received: May 2, 2002
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Epilepsy
 Drug: Talampanel
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Reduction in frequency of partial seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change in frequency of recognizable seizures as measured by entries in a seizure diary


Secondary Outcome Measures:
  • The number of seizure-free days and percent responders [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline


Enrollment: 190
Study Start Date: January 2002
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 2, 2002
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013