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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00567424
• Other study ID #: NEC107055
• Status: Withdrawn
• Phase: Phase 2
• First received: July 20, 2006
• Last updated: April 1, 2013
• Start date: July 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• GW273225

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	Amherst	New York
United States	GSK Clinical Trials Call Center	Baltimore	Maryland
United States	GSK Clinical Trials Call Center	Boston	Massachusetts
United States	GSK Clinical Trials Call Center	Burlington	Vermont
United States	GSK Clinical Trials Call Center	Chicago	Illinois
United States	GSK Clinical Trials Call Center	Cleveland	Ohio
United States	GSK Clinical Trials Call Center	Dallas	Texas
United States	GSK Clinical Trials Call Center	Durham	North Carolina
United States	GSK Clinical Trials Call Center	Iowa City	Iowa
United States	GSK Clinical Trials Call Center	Jacksonville	Florida
United States	GSK Clinical Trials Call Center	Little Rock	Arkansas
United States	GSK Clinical Trials Call Center	Medford	Oregon
United States	GSK Clinical Trials Call Center	Phoenix	Arizona
United States	GSK Clinical Trials Call Center	Portland	Oregon
United States	GSK Clinical Trials Call Center	Portland	Oregon
United States	GSK Clinical Trials Call Center	Richmond	Virginia
United States	GSK Clinical Trials Call Center	Roanoke	Virginia
United States	GSK Clinical Trials Call Center	Rochester	Minnesota
United States	GSK Clinical Trials Call Center	San Jose	California
United States	GSK Clinical Trials Call Center	Santa Monica	California
United States	GSK Clinical Trials Call Center	Seattle	Washington
United States	GSK Clinical Trials Call Center	Springfield	Illinois
United States	GSK Clinical Trials Call Center	Springfield	Missouri
United States	GSK Clinical Trials Call Center	St. Cloud	Minnesota
United States	GSK Clinical Trials Call Center	St. Louis	Missouri
United States	GSK Clinical Trials Call Center	Sun City	Arizona
United States	GSK Clinical Trials Call Center	Tallahassee	Florida
United States	GSK Clinical Trials Call Center	Tampa	Florida
United States	GSK Clinical Trials Call Center	Toledo	Ohio
United States	GSK Clinical Trials Call Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
Secondary	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.