Clinical trial NCT00567424: GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Epilepsy
Keywords: epilepsy
refractory
seizure
drug interactions
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Sun City
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Little Rock
country: United States
facility: GSK Clinical Trials Call Center
state: Arkansas
city: San Jose
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Santa Monica
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Jacksonville
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Tallahassee
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Tampa
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Springfield
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Iowa City
country: United States
facility: GSK Clinical Trials Call Center
state: Iowa
city: Wichita
country: United States
facility: GSK Clinical Trials Call Center
state: Kansas
city: Baltimore
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Boston
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Rochester
country: United States
facility: GSK Clinical Trials Call Center
state: Minnesota
city: St. Cloud
country: United States
facility: GSK Clinical Trials Call Center
state: Minnesota
city: Springfield
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St. Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Amherst
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Durham
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Cleveland
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Toledo
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Medford
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Dallas
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Burlington
country: United States
facility: GSK Clinical Trials Call Center
state: Vermont
city: Richmond
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Roanoke
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Seattle
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: