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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014