Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or...
Date First Received: July 20, 2006
Last Updated: December 3, 2007
Verified by: GlaxoSmithKline, December 2007
Clinical Trial Phase: Phase 2 | Start Date: July 2006
Overall Status: Terminated
Estimated Enrollment: 50
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: GW273225
Outcome Measures for this Clinical Trial
Primary Measures
- Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
Secondary 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.
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567424
Study ID Number: NEC107055
ClinicalTrials.gov Identifier: NCT00567424
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
