GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures - Full Text View

Purpose

Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin

Condition	Intervention	Phase
Epilepsy	Drug: GW273225	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized

Resource links provided by NLM:

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

MedlinePlus related topics: Drug Reactions Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).

Secondary Outcome Measures:

Safety/tolerability of GW273225 in adults with refractory epilepsy Efficacy of GW273225 in adults with refractory epilepsy Potential initial starting doses for a subsequent placebo-controlled dose-ranging Phase IIb study.

Enrollment:	0
Study Start Date:	July 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Confident diagnosis of epilepsy
Currently on VPA, CBZ or PHT
>or= 4 seizures/4 weeks prior to screen

Exclusion criteria:

Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)).
Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567424

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Locations

United States, Arizona
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85054
GSK Clinical Trials Call Center
Sun City, Arizona, United States, 85351
United States, Arkansas
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72205
United States, California
GSK Clinical Trials Call Center
San Jose, California, United States, 95128
GSK Clinical Trials Call Center
Santa Monica, California, United States, 90404
United States, Florida
GSK Clinical Trials Call Center
Jacksonville, Florida, United States, 32209
GSK Clinical Trials Call Center
Tallahassee, Florida, United States, 32308
GSK Clinical Trials Call Center
Tampa, Florida, United States, 33613
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60612
GSK Clinical Trials Call Center
Springfield, Illinois, United States, 62704
United States, Iowa
GSK Clinical Trials Call Center
Iowa City, Iowa, United States, 52242
United States, Kansas
GSK Clinical Trials Call Center
Wichita, Kansas, United States, 67214
United States, Maryland
GSK Clinical Trials Call Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
GSK Clinical Trials Call Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
GSK Clinical Trials Call Center
Rochester, Minnesota, United States, 55905
GSK Clinical Trials Call Center
St. Cloud, Minnesota, United States, 56303
United States, Missouri
GSK Clinical Trials Call Center
Springfield, Missouri, United States, 65804
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63310
United States, New York
GSK Clinical Trials Call Center
Amherst, New York, United States, 14226
United States, North Carolina
GSK Clinical Trials Call Center
Durham, North Carolina, United States, 27560
United States, Ohio
GSK Clinical Trials Call Center
Cleveland, Ohio, United States, 44195
GSK Clinical Trials Call Center
Toledo, Ohio, United States, 43614
United States, Oregon
GSK Clinical Trials Call Center
Medford, Oregon, United States, 97504
GSK Clinical Trials Call Center
Portland, Oregon, United States, 97239-3098
GSK Clinical Trials Call Center
Portland, Oregon, United States, 97225
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75230
United States, Vermont
GSK Clinical Trials Call Center
Burlington, Vermont, United States, 05401
United States, Virginia
GSK Clinical Trials Call Center
Richmond, Virginia, United States, 23219
GSK Clinical Trials Call Center
Roanoke, Virginia, United States, 24018
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00567424 History of Changes
Other Study ID Numbers:	NEC107055
Study First Received:	July 20, 2006
Last Updated:	April 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

epilepsy
refractory
seizure
drug interactions
pharmacokinetics

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013