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

May 2, 2002
March 15, 2011
January 2002
January 2006   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00034814 on ClinicalTrials.gov Archive Site
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
Not Provided
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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.

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Epilepsy
  • 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
  • Placebo Comparator: 1
    Enzyme-inducing placebo TID
    Intervention: Drug: Placebo
  • Experimental: 2
    Enzyme-inducing Talampanel 35 mg TID
    Intervention: Drug: Talampanel
  • Experimental: 3
    Enzyme-inducing TLP 50mg TID
    Intervention: Drug: Talampanel
  • Placebo Comparator: 4
    Non-enzyme-inducing placebo TID
    Intervention: Drug: Placebo
  • Experimental: 5
    Non-enzyme-inducing TLP 25mg TID
    Intervention: Drug: Talampanel
  • Experimental: 6
    Non-enzyme-inducing TLP 35mg TID
    Intervention: Drug: Talampanel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00034814
IXL-201-14-189
Not Provided
Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Not Provided
Not Provided
Teva Pharmaceutical Industries
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP