Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
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This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase. [ Time Frame: 24 Weeks ]
Secondary Outcome Measures :
Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics [ Time Frame: 24 Weeks ]
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Ages Eligible for Study:
13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of epilepsy with partial seizures for more than 24 weeks.
Must experience at least 8 partial seizures during an 8-week Baseline Phase.
Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.
Previous treatment with lamotrigine.
Exhibits any primary generalized seizures.
Receiving treatment with felbamate or currently following the ketogenic diet.
Pregnant, breastfeeding, or planning to become pregnant.