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

An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567424

Enrollment

Registered

2007-12-05

Start date

2006-07-31

Completion date

2008-03-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

epilepsy, refractory, seizure, drug interactions, pharmacokinetics

Brief summary

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

Interventions

DRUGGW273225

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).	—

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026