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

This study has been withdrawn prior to enrollment.
(No longer viable)
Information provided by:
GlaxoSmithKline Identifier:
First received: July 20, 2006
Last updated: April 1, 2013
Last verified: April 2013
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin

Condition Intervention Phase
Epilepsy Drug: GW273225 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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.

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00567424

  Show 30 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information Identifier: NCT00567424     History of Changes
Other Study ID Numbers: NEC107055
Study First Received: July 20, 2006
Last Updated: April 1, 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 processed this record on August 17, 2017