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

This study has been terminated.

First Received on July 20, 2006. Last Updated on December 3, 2007 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00567424

Purpose

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

Condition	Intervention	Phase
Epilepsy	Drug: GW273225	Phase II

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:

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.

Estimated Enrollment:	50
Study Start Date:	July 2006

Eligibility

Criteria

Inclusion criteria:

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

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:	December 3, 2007
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 February 09, 2012