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

Phase 2WithdrawnNCT00567424

GlaxoSmithKline

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Epilepsy

Interventions

GW273225DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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