Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
1 other identifier
interventional
226
8 countries
103
Brief Summary
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
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 May 2006
Typical duration for phase_3
103 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
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 19, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
November 25, 2009
CompletedJanuary 2, 2017
November 1, 2016
2.5 years
July 19, 2006
September 8, 2009
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.
From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)
Secondary Outcomes (7)
The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Time to Discontinuation in the Treatment Phase
From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Percentage of Participants Meeting Escape Criteria in the Treatment Phase
Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)
Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)
Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase
The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)
- +2 more secondary outcomes
Study Arms (2)
lamotrigine 300
EXPERIMENTAL300 mg/day treatment
lamotrigine 250
EXPERIMENTAL250 mg/day treatment
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female ≥13 years of age
- Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeks prior to the Baseline Phase
- Have a documented history of partial seizures such that the investigator must judge that the subject is likely to have at least 4 partial seizures during the 8-week Baseline Phase.
- Have experienced at least 4 partial seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4-week (i.e., 28-day) period.
- NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following:
- A complete daily seizure diary that includes the number, and type (i.e., simple or complex partial seizures with or without secondary generalization), of seizures experienced each day for up to 28 consecutive days immediately prior to the prospective Baseline Phase
- Stability of prescribed dosages of background antiepileptic drug (AED)
- Compliance with background AED
- All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.
- be currently receiving AED monotherapy treatment with a stable regimen of a non-enzyme inducing AED for at least four weeks prior to starting the Baseline Phase.
- be able and willing to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain and accurate, complete, written daily seizure diary for the entire duration of the study.
- be able to comply with the dosing of study drugs, background AED, and all study procedures.
- understand and sign written informed consent, or will have a parent or a legally authorized representative who has done so, prior to the performance of any study assessments
- if female, and of childbearing potential be using an acceptable form of birth control, to include one of the following:
- Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 2 weeks).
- +6 more criteria
You may not qualify if:
- Exhibits any primary generalized seizures (e.g., absence, myoclonic primary generalized tonic-clonic seizures).
- Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
- Is taking an enzyme-inducing AED (EIAED - e.g. carbamazepine, phenytoin, phenobarbital, primidone) or is taking more than 1 background AED.
- Is currently taking lamotrigine (LTG) or has previously had an adequate trial of LTG.
- Is currently taking felbamate
- Is using hormone therapy
- Is abusing alcohol and/or other substances
- Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
- Is receiving chronic treatment with any medication that could influence seizure control
- NOTE: Use of benzodiazepines is allowed as specified in Section 8.1.2
- Is currently following the ketogenic diet.
- Is using vagal nerve stimulation
- Is planning surgery to control seizures during the study.
- Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
- Is suffering from acute or progressive neurological disease, severe psychiatric disease or severe mental abnormality that is likely to interfere with the objectives of the study.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (103)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Litchfield Park, Arizona, 85340, United States
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Phoenix, Arizona, 85003, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
GSK Investigational Site
Tucson, Arizona, 85741, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Danbury, Connecticut, 06810, United States
GSK Investigational Site
Fairfield, Connecticut, 06824, United States
GSK Investigational Site
Newark, Delaware, 19713, United States
GSK Investigational Site
Jacksonville, Florida, 32224, United States
GSK Investigational Site
Loxahatchee Groves, Florida, 33470, United States
GSK Investigational Site
Sunrise, Florida, 33351, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Flossmoor, Illinois, 60422, United States
GSK Investigational Site
Urbana, Illinois, 61801, United States
GSK Investigational Site
Des Moines, Iowa, 50309, United States
GSK Investigational Site
Lexington, Kentucky, 40513, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
Bethesda, Maryland, 20817, United States
GSK Investigational Site
Glen Burnie, Maryland, 21061, United States
GSK Investigational Site
Pikesville, Maryland, 21208, United States
GSK Investigational Site
Springfield, Massachusetts, 01104, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Saint Cloud, Minnesota, 56303, United States
GSK Investigational Site
Hattiesburg, Mississippi, 39401, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Las Vegas, Nevada, 81902, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Edison, New Jersey, 08818, United States
GSK Investigational Site
Vorhees, New Jersey, 08043, United States
GSK Investigational Site
Lawrence, New York, 11559, United States
GSK Investigational Site
Plainview, New York, 11803, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Asheville, North Carolina, 28803, United States
GSK Investigational Site
Columbus, Ohio, 43210-1296, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77025, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Temple, Texas, 76502, United States
GSK Investigational Site
Midvale, Utah, 84047, United States
GSK Investigational Site
Renton, Washington, 98055, United States
GSK Investigational Site
Charleston, West Virginia, 25301, United States
GSK Investigational Site
Morgantown, West Virginia, 26506, United States
GSK Investigational Site
Madison, Wisconsin, 53715, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Capital Federal, Buenos Aires, 1181, Argentina
GSK Investigational Site
Capital Fefderal, Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Providencia / Santiago, RegiĂ³n Metro de Santiago, 7500710, Chile
GSK Investigational Site
Santiago, RegiĂ³n Metro de Santiago, 7560356, Chile
GSK Investigational Site
Santiago, RegiĂ³n Metro de Santiago, Chile
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
San Juan, Puerto Rico, 00918, Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00936, Puerto Rico
GSK Investigational Site
Moscow, 105066, Russia
GSK Investigational Site
Moscow, 117049, Russia
GSK Investigational Site
Moscow, 125412, Russia
GSK Investigational Site
Saint Petersburg, 193019, Russia
GSK Investigational Site
Saint Petersburg, 193167, Russia
GSK Investigational Site
Saint Petersburg, 194291, Russia
GSK Investigational Site
Samara, 443095, Russia
GSK Investigational Site
Yekaterinburg, 620102, Russia
GSK Investigational Site
Busan, 614-735, South Korea
GSK Investigational Site
Daegu, 700-712, South Korea
GSK Investigational Site
Daejeon, 301-721, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 135-170, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Dnipro, 49005, Ukraine
GSK Investigational Site
Donetsk, 83037, Ukraine
GSK Investigational Site
Kharkiv, 61068, Ukraine
GSK Investigational Site
Kyiv, 02660, Ukraine
GSK Investigational Site
Kyiv, Ukraine
GSK Investigational Site
Luhansk, 91045, Ukraine
GSK Investigational Site
Lviv, 79021, Ukraine
GSK Investigational Site
Odesa, 65006, Ukraine
GSK Investigational Site
Poltava, Ukraine
GSK Investigational Site
Vinnitsa, 21005, Ukraine
GSK Investigational Site
Zaporizhzhya, 69057, Ukraine
Related Publications (2)
French JA, Hammer AE, Vuong A, Messenheimer JA. Analysis of three lamotrigine extended-release clinical trials: comparison of pragmatic ITT and LOCF methodologies. Epilepsy Res. 2012 Aug;101(1-2):141-7. doi: 10.1016/j.eplepsyres.2012.03.015. Epub 2012 Apr 10.
PMID: 22497754BACKGROUNDFrench JA, Temkin NR, Shneker BF, Hammer AE, Caldwell PT, Messenheimer JA. Lamotrigine XR conversion to monotherapy: first study using a historical control group. Neurotherapeutics. 2012 Jan;9(1):176-84. doi: 10.1007/s13311-011-0088-3.
PMID: 22139591BACKGROUND
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2006
First Posted
July 21, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
January 2, 2017
Results First Posted
November 25, 2009
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.