Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

Inclusion criteria:

• Male or Female ≥13 years of age

• Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeksprior to the Baseline Phase

• Have a documented history of partial seizures such that the investigator must judgethat the subject is likely to have at least 4 partial seizures during the 8-weekBaseline Phase.

• Have experienced at least 4 partial seizures (i.e., simple or complex partial seizureswith or without secondary generalization) during an 8-week (i.e., 56 days) prospectiveBaseline 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 takethe place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase forsubjects providing reliable documentation of the following:

1. A complete daily seizure diary that includes the number, and type (i.e., simpleor complex partial seizures with or without secondary generalization), ofseizures experienced each day for up to 28 consecutive days immediately prior tothe 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 fourweeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus theprospective Baseline Phases must equal the 56 consecutive days prior to the start of dosingwith study drug.

• be currently receiving AED monotherapy treatment with a stable regimen of a non-enzymeinducing 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, orhas 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 studyprocedures.

• understand and sign written informed consent, or will have a parent or a legallyauthorized representative who has done so, prior to the performance of any studyassessments

• 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 studydrug, throughout the clinical trial, and for a period after the trial to accountfor 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 thesole 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., spermicideplus a male condom or a female diaphragm). NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal areconsidered to be of non-childbearing potential. NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) andestrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., forcontraception or hormone replacement therapy) is not allowed.

Exclusion criteria:

• Exhibits any primary generalized seizures (e.g., absence, myoclonic primarygeneralized tonic-clonic seizures).

• Has had status epilepticus within the 24 weeks prior to, or during, the BaselinePhase.

• 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 aninvestigational drug anytime during the study.

• Is receiving chronic treatment with any medication that could influence seizurecontrol

• 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 withinthe three weeks after the last dose of study drug.

• Is suffering from acute or progressive neurological disease, severe psychiatricdisease or severe mental abnormality that is likely to interfere with the objectivesof the study.

• Has any clinically significant cardiac, renal, hepatic condition, or a condition thataffects the absorption, distribution, metabolism or excretion of drugs.