Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Condition(s) targeted: Epilepsy

Intervention: Lamotrigine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Call Centre, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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

Official title: Lamotrigine Extended-Release in Elderly Patients With Epilepsy

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

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

Secondary outcome:

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

Changes in seizure control Changes in safety assessments (vital signs, hematology and blood chemistry, lipid levels)

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Birmingham, Alabama 35294-0021, United States; Completed

GSK Investigational Site, Gilbert, Arizona 85234, United States; Completed

GSK Investigational Site, Litchfield Park, Arizona 85340, United States; Completed

GSK Investigational Site, Phoenix, Arizona 85003, United States; Completed

GSK Investigational Site, Phoenix, Arizona 85013, United States; Completed

GSK Investigational Site, Fullteron, California 92835, United States; Recruiting

GSK Investigational Site, Los Angeles, California 90073, United States; Recruiting

GSK Investigational Site, Pasadena, California 91106, United States; Completed

GSK Investigational Site, Fresno, California 93710, United States; Recruiting

GSK Investigational Site, Fort Collins, Colorado 80524, United States; Recruiting

GSK Investigational Site, Newark, Delaware 19713, United States; Completed

GSK Investigational Site, Jacksonville, Florida 32224, United States; Recruiting

GSK Investigational Site, Gainesville, Florida 32610, United States; Completed

GSK Investigational Site, Melbourne, Florida 32901, United States; Completed

GSK Investigational Site, Tampa, Florida 33613, United States; Completed

GSK Investigational Site, Jacksonville, Florida 32266, United States; Completed

GSK Investigational Site, Miami, Florida 33136, United States; Completed

GSK Investigational Site, Sarasota, Florida 34233, United States; Completed

GSK Investigational Site, Atlanta, Georgia 30322, United States; Recruiting

GSK Investigational Site, Atlanta, Georgia 30309, United States; Completed

GSK Investigational Site, Suwanee, Georgia 30024, United States; Completed

GSK Investigational Site, Boise, Idaho 83702, United States; Recruiting

GSK Investigational Site, Springfield, Illinois 62702, United States; Completed

GSK Investigational Site, Indianapolis, Indiana 46256, United States; Completed

GSK Investigational Site, Fort Wayne, Indiana 46805, United States; Completed

GSK Investigational Site, Wichita, Kansas 67214, United States; Completed

GSK Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

GSK Investigational Site, Scarborough, Maine 4074, United States; Recruiting

GSK Investigational Site, Hopedale, Massachusetts 01747, United States; Not yet recruiting

GSK Investigational Site, Burlington, Massachusetts 01805, United States; Recruiting

GSK Investigational Site, Traverse City, Michigan 49684, United States; Recruiting

GSK Investigational Site, Minneapolis, Minnesota 55422, United States; Recruiting

GSK Investigational Site, St. Paul, Minnesota 55102, United States; Recruiting

GSK Investigational Site, Kansas City, Missouri 64111, United States; Active, not recruiting

GSK Investigational Site, Chesterfield, Missouri 63017, United States; Completed

GSK Investigational Site, Henderson, Nevada 89014, United States; Completed

GSK Investigational Site, Newark, New Jersey 07103, United States; Completed

GSK Investigational Site, Summit, New Jersey 07901, United States; Completed

GSK Investigational Site, Camden, New Jersey 08103, United States; Recruiting

GSK Investigational Site, Cedarhurst, New York 11516, United States; Completed

GSK Investigational Site, Rochester, New York 14642, United States; Recruiting

GSK Investigational Site, Schenectady, New York 12308, United States; Completed

GSK Investigational Site, Columbus, Ohio 43210, United States; Recruiting

GSK Investigational Site, Columbus, Ohio 43210, United States; Completed

GSK Investigational Site, Toledo, Ohio 43614, United States; Completed

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States; Completed

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States; Recruiting

GSK Investigational Site, Sellersville, Pennsylvania 18960, United States; Recruiting

GSK Investigational Site, Philadelphia, Pennsylvania 19102, United States; Completed

GSK Investigational Site, Pittsburgh, Pennsylvania 15240, United States; Recruiting

GSK Investigational Site, Cordova, Tennessee 38018, United States; Completed

GSK Investigational Site, Nashville, Tennessee 37232, United States; Completed

GSK Investigational Site, Germantown, Tennessee 38139, United States; Completed

GSK Investigational Site, Columbia, Tennessee 38401, United States; Completed

GSK Investigational Site, Dallas, Texas 75230, United States; Recruiting

GSK Investigational Site, Dallas, Texas 75214, United States; Not yet recruiting

GSK Investigational Site, Houston, Texas 77030, United States; Completed

GSK Investigational Site, Temple, Texas 76508, United States; Recruiting

GSK Investigational Site, Richmond, Virginia 23298, United States; Completed

GSK Investigational Site, Bremerton, Washington 98310, United States; Recruiting

GSK Investigational Site, Madison, Wisconsin 53715, United States; Recruiting

GSK Investigational Site, Milwaukee, Wisconsin 53226, United States; Completed

GSK Investigational Site, Milwaukee, Wisconsin 53215, United States; Completed

website

Starting date: August 2007
Ending date: September 2009
Last updated: October 15, 2009