Multicenter Trial for Adults With Partial Seizures - Tabular View

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	May 6, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Epilepsy
Intervention ^ICMJE	Drug: Talampanel Drug: Placebo
Study Arms / Comparison Groups	Placebo Comparator: Enzyme-inducing placebo TID Experimental: Enzyme-inducing Talampanel 35 mg TID Experimental: Enzyme-inducing TLP 50mg TID Placebo Comparator: Non-enzyme-inducing placebo TID Experimental: Non-enzyme-inducing TLP 25mg TID Experimental: Non-enzyme-inducing TLP 35mg TID
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	190
Completion Date
Primary Completion Date
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	United States, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00034814
Responsible Party	Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience
Study ID Numbers ^ICMJE	IXL-201-14-189
Study Sponsor ^ICMJE	Teva Global Respiratory Research LLC
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Teva Global Respiratory Research LLC
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP