Multicenter Trial for Adults With Partial Seizures - Full Text View

Sponsored by:	Teva Global Respiratory Research LLC
Information provided by:	Teva Global Respiratory Research LLC
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:	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 Global Respiratory Research LLC:

Enrollment:

190

Arms	Assigned Interventions
1: Placebo Comparator Enzyme-inducing placebo TID	Drug: Placebo Enzyme-inducing placebo TID
2: Experimental Enzyme-inducing Talampanel 35 mg TID	Drug: Talampanel Enzyme-inducing Talampanel 35 mg TID
3: Experimental Enzyme-inducing TLP 50mg TID	Drug: Talampanel Enzyme-inducing TLP 50mg TID
4: Placebo Comparator Non-enzyme-inducing placebo TID	Drug: Placebo Non-enzyme-inducing placebo TID
5: Experimental Non-enzyme-inducing TLP 25mg TID	Drug: Talampanel Non-enzyme-inducing TLP 25mg TID
6: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034814

Show 26 Study Locations

Sponsors and Collaborators

Teva Global Respiratory Research LLC

More Information

No publications provided

Responsible Party:	Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development )
Study ID Numbers:	IXL-201-14-189
Study First Received:	May 2, 2002
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00034814 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 11, 2009