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 evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. [ Time Frame: 36 Months ]
Secondary Outcome Measures
Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events [ Time Frame: 36 Months ]
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:
1 Month to 24 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Have a confident diagnosis of epilepsy
Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
Have no underlying chronic metabolism problems
Have normal lab results
Have a normal electrocardiogram (ECG)
Have a diagnosis of severe, progressive myoclonus.
Have seizures not related to epilepsy.
Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
Have progressive or unstable condition of the nervous system.
Used experimental medication within 30 of enrollment into the study.
Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
Current use of the medication felbamate.
Current use of adrenocorticotrophic hormone (ACTH).