Clinical Evaluation of BW430C in Epilepsy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 2006

Last Updated Date

July 16, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of rash in the first 8 weeks of treatment, in Japanese patients with epilepsy when administered at the same starting doses with the same dose escalation method as recommended Global Data Sheet for patients taking Valproic acid. [ Time Frame: 8 Weeks ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00395694 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of BW430C for prevention of seizures in Japanese patients with epilepsy when administered at the same starting doses and then maintained at an optimal maintenance dose. [ Time Frame: 8 Weeks ]

Original Secondary Outcome Measures ^ICMJE

Efficacy of BW430C for prevention of seizures in Japanese patients with epilepsy when administered at the same starting doses and then maintained at an optimal maintenance dose.

Descriptive Information

Brief Title ^ICMJE

Clinical Evaluation of BW430C in Epilepsy

Official Title ^ICMJE

Clinical Evaluation of BW430C in Epilepsy <Phase III Study>

Brief Summary

To evaluate safety information of BW430C when administered using the lower starting doses and slower dose escalations as recommended Global Data Sheet

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: LAMICTAL (BW430C)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Epilepsy with partial seizures
Tonic clonic seizures
Generalized seizures of Lennox-Gastaut
Subjects whose seizures are easily recognizable at least one seizure per month and counts for 8 consecutive weeks prior to the start of the study drug.
Concurrent AEDs: Subjects taking concurrent VPA.

Exclusion criteria:

Previous participation in a study of Lamictal
Known hypersensitivity to any drugs
Pregnant women
nursing mothers
women who may be pregnant
women contemplating pregnancy during the study period

Gender

Both

Ages

2 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00395694

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LAM107844

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP