DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Lamotrigine Extended-Release In Elderly Patients With Epilepsy

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Lamotrigine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event

Secondary outcome:

Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study

Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study

Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period

Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale

Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale

Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study

Change From Baseline in the Height at the Indicated Time Points in the Study

Change From Baseline in the Weight at the Indicated Time Points in the Study

Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study

Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study

Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study

Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study

Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study

Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study

Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study

Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study

Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points

Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA

Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA

Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA

Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA

Eligibility

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

Locations and Contacts

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

GSK Investigational Site, Gilbert, Arizona 85234, United States

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

GSK Investigational Site, Phoenix, Arizona 85003, United States

GSK Investigational Site, Phoenix, Arizona 85013, United States

GSK Investigational Site, Fresno, California 93710, United States

GSK Investigational Site, Fullteron, California 92835, United States

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

GSK Investigational Site, Pasadena, California 91106, United States

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

GSK Investigational Site, Newark, Delaware 19713, United States

GSK Investigational Site, Gainesville, Florida 32610, United States

GSK Investigational Site, Jacksonville, Florida 32224, United States

GSK Investigational Site, Jacksonville, Florida 32266, United States

GSK Investigational Site, Melbourne, Florida 32901, United States

GSK Investigational Site, Miami, Florida 33136, United States

GSK Investigational Site, Ponte Vedra Beach, Florida 32082, United States

GSK Investigational Site, Sarasota, Florida 34233, United States

GSK Investigational Site, Atlanta, Georgia 30309, United States

GSK Investigational Site, Atlanta, Georgia 30322, United States

GSK Investigational Site, Suwanee, Georgia 30024, United States

GSK Investigational Site, Boise, Idaho 83702, United States

GSK Investigational Site, Springfield, Illinois 62702, United States

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

GSK Investigational Site, Indianapolis, Indiana 46256, United States

GSK Investigational Site, Wichita, Kansas 67214, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Scarborough, Maine 4074, United States

GSK Investigational Site, Burlington, Massachusetts 01805, United States

GSK Investigational Site, Hopedale, Massachusetts 01747, United States

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

GSK Investigational Site, Minneapolis, Minnesota 55422, United States

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

GSK Investigational Site, Chesterfield, Missouri 63017, United States

GSK Investigational Site, Kansas City, Missouri 64111, United States

GSK Investigational Site, Henderson, Nevada 89014, United States

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

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

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

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

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

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

GSK Investigational Site, Columbus, Ohio 43210, United States

GSK Investigational Site, Toledo, Ohio 43614, United States

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

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19102, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15240, United States

GSK Investigational Site, Sellersville, Pennsylvania 18960, United States

GSK Investigational Site, Columbia, Tennessee 38401, United States

GSK Investigational Site, Cordova, Tennessee 38018, United States

GSK Investigational Site, Germantown, Tennessee 38139, United States

GSK Investigational Site, Nashville, Tennessee 37232, United States

GSK Investigational Site, Dallas, Texas 75214, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Temple, Texas 76508, United States

GSK Investigational Site, Richmond, Virginia 23298, United States

GSK Investigational Site, Bremerton, Washington 98310, United States

GSK Investigational Site, Madison, Wisconsin 53715, United States

GSK Investigational Site, Milwaukee, Wisconsin 53215, United States

GSK Investigational Site, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: August 2007
Last updated: August 16, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017