Clinical Evaluation of BW430C in Epilepsy - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00395694

Purpose

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

Condition	Intervention	Phase
Epilepsy	Drug: lamictal	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Evaluation of BW430C in Epilepsy <Phase III Study>

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Rashes

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	96
Study Start Date:	August 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lamictal	Drug: lamictal anti-epileptic drug

Eligibility

Ages Eligible for Study:	2 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395694

Locations

Japan
GSK Investigational Site
Kumamoto, Japan, 860-8556

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00395694 History of Changes
Other Study ID Numbers:	LAM107844
Study First Received:	November 2, 2006
Last Updated:	December 3, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

epilepsy
safety evaluation for initial dose
patients with Valproic acid
Incidence of rash

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012