Lamotrigine Extended-Release In Elderly Patients With Epilepsy
Lamotrigine Extended-Release in Elderly Patients With Epilepsy
1 other identifier
interventional
122
1 country
63
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2007
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 13, 2007
CompletedFirst Posted
Study publicly available on registry
August 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
January 13, 2012
CompletedJanuary 18, 2017
November 1, 2016
2.9 years
August 13, 2007
July 15, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.
From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)
Secondary Outcomes (21)
Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study
Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)
Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study
Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)
Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period
Week 30 or 33
Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale
Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale
Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])
- +16 more secondary outcomes
Study Arms (1)
Lamotrigine
EXPERIMENTALOpen-label lamotrigine
Interventions
Eligibility Criteria
You may qualify if:
- Confident diagnosis of epilepsy
- Currently treated with one or two antiepileptic medications
- Able to complete a seizure diary
You may not qualify if:
- History of hypersensitivity to lamotrigine
- Progressive diseases that would interfere with the study objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (63)
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
Irvine, California, 92618, 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
Saint 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, 19102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2007
First Posted
August 15, 2007
Study Start
August 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
January 18, 2017
Results First Posted
January 13, 2012
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.