NCT00567424|WithdrawnPhase 2

Study Stopped

No longer viable

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

NEC107055

Study Type

interventional

Target

N/A

Locations

1 country

Sites

Timeline

RegisteredDec 2007

StartedJul 2006

CompletionMar 2008

Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Jul 2006

Geographic Reach

1 country

30 active sites

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

July 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed

1.4 years until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed

Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

July 20, 2006

Last Update Submit

April 1, 2013

Conditions

Epilepsy

Keywords

epilepsyrefractoryseizuredrug interactionspharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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.

Interventions

GW273225DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Confident diagnosis of epilepsy
Currently on VPA, CBZ or PHT
\>or= 4 seizures/4 weeks prior to screen

You may not qualify if:

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.

Contact the study team to confirm eligibility.