Multicenter Trial for Adults With Partial Seizures - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00034814

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 II

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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: GYKI 53773

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 February 12, 2012