This study is being conducted to determine the effectiveness of a lower monotherapy dose of
lamotrigine than that currently approved.
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion criteria:
- 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:
1. 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
2. Stability of prescribed dosages of background antiepileptic drug (AED)
3. 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:
1. 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).
2. Consistent and correct use of one of the following methods of birth control:
Male partner who is sterile prior to the female subject's entry into the study and is the
sole sexual partner for that female subject.
Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
Double barrier method consisting of spermicide plus a mechanical barrier (e. g., spermicide
plus a male condom or a female diaphragm).
NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are
considered to be of non-childbearing potential.
NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) and
estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e. g., for
contraception or hormone replacement therapy) is not allowed.
Exclusion criteria:
- 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.
- Has any clinically significant cardiac, renal, hepatic condition, or a condition that
affects the absorption, distribution, metabolism or excretion of drugs.
GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Argentina
GSK Investigational Site, Ciudad Autónoma de Buenos Aires 1425, Argentina
GSK Investigational Site, San Jose, Costa Rica
GSK Investigational Site, Busan 614-735, Korea, Republic of
GSK Investigational Site, Daegu 700-712, Korea, Republic of
GSK Investigational Site, Daejeon 301-721, Korea, Republic of
GSK Investigational Site, Seoul 138-736, Korea, Republic of
GSK Investigational Site, Seoul 110-744, Korea, Republic of
GSK Investigational Site, Seoul 120-752, Korea, Republic of
GSK Investigational Site, Seoul 135-170, Korea, Republic of
GSK Investigational Site, San Juan 00918, Puerto Rico
GSK Investigational Site, San Juan 00936, Puerto Rico
GSK Investigational Site, Ekaterinburg 620102, Russian Federation
GSK Investigational Site, Moscow 105066, Russian Federation
GSK Investigational Site, Moscow 117049, Russian Federation
GSK Investigational Site, Moscow 125412, Russian Federation
GSK Investigational Site, Samara 443095, Russian Federation
GSK Investigational Site, St.-Petersburg 193019, Russian Federation
GSK Investigational Site, St.-Petersburg 194291, Russian Federation
GSK Investigational Site, St.Petersburg 193167, Russian Federation
GSK Investigational Site, Dnepropetrovsk 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, Lugansk 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
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, Capital Federal, Buenos Aires 1181, Argentina
GSK Investigational Site, Capital Fefderal, Buenos Aires, Argentina
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, 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 40536, United States
GSK Investigational Site, Lexington, Kentucky 40513, 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, St. 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 63110, United States
GSK Investigational Site, St. Louis, Missouri 63104, 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, Providencia / Santiago, Región Metro De Santiago 7500710, Chile
GSK Investigational Site, Santiago, Región Metro De Santiago 7560356, Chile
GSK Investigational Site, Santiago, Región Metro De Santiago, Chile
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
French 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. Review.
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.