Lamotrigine Extended-Release In Elderly Patients With Epilepsy

This study is currently recruiting participants.

Verified by GlaxoSmithKline, November 2009

First Received: August 13, 2007 Last Updated: November 25, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00516139

Purpose

This study is being conducted to determine the safety and tolerability of lamotrigine in elderly patients with epilepsy

Condition	Intervention	Phase
Epilepsy	Drug: Lamotrigine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Lamotrigine Extended-Release in Elderly Patients With Epilepsy

Resource links provided by NLM:

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

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Frequency of treatment-emergent adverse events at 15 weeks and 28 weeks

Secondary Outcome Measures:

Frequency of treatment-emergent adverse events at 15 weeks and 28 weeks
Serum concentration of lamotrigine at 4,7,11,15,24 and 28 weeks Changes in seizure control at 15 weeks and 28 weeks Changes in safety assessments (vital signs, hematology and blood chemistry, lipid levels) at 15 weeks and 28 weeks
Serum concentration of lamotrigine [ Time Frame: at 4,7,11,15,24 and 28 weeks ]
Changes in seizure control Changes in safety assessments (vital signs, hematology and blood chemistry, lipid levels) [ Time Frame: at 15 weeks and 28 weeks ]

Estimated Enrollment:	170
Study Start Date:	August 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Confident diagnosis of epilepsy
Currently treated with one or two antiepileptic medications
Able to complete a seizure diary

Exclusion criteria:

History of hypersensitivity to lamotrigine
Progressive diseases that would interfere with the study objectives

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516139

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 63 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, Call Centre

GlaxoSmithKline

More Information

Additional Information:

website

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LEP105972, GI267119
Study First Received:	August 13, 2007
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00516139 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Epilepsy elderly seizure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions

Membrane Transport Modulators
Epilepsy
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010