Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
13 Years and older (Child, Adult, Senior)
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.