Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: lamotrigine, 300 mg/day; lamotrigine, 250 mg/day
Intervention description: 300 mg/day; 250 mg/day
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: epilepsy; lamotrigine; Lamictal; monotherapy

Summary:

      This study is being conducted to determine the effectiveness of a lower monotherapy dose of
      lamotrigine than that currently approved.
    

Eligibility criteria:

        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.