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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00567424
Recruitment Status : Withdrawn (No longer viable)
First Posted : December 5, 2007
Last Update Posted : April 4, 2013
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Brief Summary:
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin

Condition or disease Intervention/treatment Phase
Epilepsy Drug: GW273225 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567424

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

ClinicalTrials.gov Identifier: NCT00567424     History of Changes
Other Study ID Numbers: NEC107055
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by GlaxoSmithKline:
drug interactions

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms