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

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	March 15, 2011
Start Date ^ICMJE	January 2002
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 15, 2011)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00034814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 15, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multicenter Trial for Adults With Partial Seizures
Official Title ^ICMJE	Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Epilepsy
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	190
Completion Date	January 2006
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00034814
Other Study ID Numbers ^ICMJE	IXL-201-14-189
Has Data Monitoring Committee	Not Provided
Responsible Party	Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc.
Study Sponsor ^ICMJE	Teva Pharmaceutical Industries
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Teva Pharmaceutical Industries
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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