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GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: GW273225 (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Clinical Trials Call Center, Phoenix, Arizona 85054, United States

GSK Clinical Trials Call Center, Sun City, Arizona 85351, United States

GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States

GSK Clinical Trials Call Center, San Jose, California 95128, United States

GSK Clinical Trials Call Center, Santa Monica, California 90404, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32209, United States

GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States

GSK Clinical Trials Call Center, Tampa, Florida 33613, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60612, United States

GSK Clinical Trials Call Center, Springfield, Illinois 62704, United States

GSK Clinical Trials Call Center, Iowa City, Iowa 52242, United States

GSK Clinical Trials Call Center, Wichita, Kansas 67214, United States

GSK Clinical Trials Call Center, Baltimore, Maryland 21287, United States

GSK Clinical Trials Call Center, Boston, Massachusetts 02215, United States

GSK Clinical Trials Call Center, Rochester, Minnesota 55905, United States

GSK Clinical Trials Call Center, St. Cloud, Minnesota 56303, United States

GSK Clinical Trials Call Center, Springfield, Missouri 65804, United States

GSK Clinical Trials Call Center, St. Louis, Missouri 63310, United States

GSK Clinical Trials Call Center, Amherst, New York 14226, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27560, United States

GSK Clinical Trials Call Center, Cleveland, Ohio 44195, United States

GSK Clinical Trials Call Center, Toledo, Ohio 43614, United States

GSK Clinical Trials Call Center, Medford, Oregon 97504, United States

GSK Clinical Trials Call Center, Portland, Oregon 97225, United States

GSK Clinical Trials Call Center, Portland, Oregon 97239-3098, United States

GSK Clinical Trials Call Center, Dallas, Texas 75230, United States

GSK Clinical Trials Call Center, Burlington, Vermont 05401, United States

GSK Clinical Trials Call Center, Richmond, Virginia 23219, United States

GSK Clinical Trials Call Center, Roanoke, Virginia 24018, United States

GSK Clinical Trials Call Center, Seattle, Washington 98104, United States

Additional Information

Starting date: July 2006
Last updated: April 1, 2013

Page last updated: August 23, 2015

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