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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00567424
First received: July 20, 2006
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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: 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:

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.

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567424

  Show 30 Study Locations
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: April 1, 2013
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 May 22, 2013