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

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

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy
• Intervention / Treatment: Drug: GW273225

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: July 20, 2006
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: epilepsy; pharmacokinetics; refractory; drug interactions; seizure
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: NEC107055