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.
Minimum age: 1 Month.
Maximum age: 24 Months.
Gender(s): Both.
INCLUSION CRITERIA:
- 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)
EXCLUSION CRITERIA:
- 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).
- Following a ketogenic diet.
- Receiving vagal nerve stimulation (VNS).
GSK Investigational Site, Tartu 51014, Estonia
GSK Investigational Site, Riga LV 1004, Latvia
GSK Investigational Site, Beirut 11072020, Lebanon
GSK Investigational Site, Rotterdam 3015 GD, Netherlands
GSK Investigational Site, Las Palmas De Gran Canaria 35016, Spain
GSK Investigational Site, Ankara, Turkey
GSK Investigational Site, Tucson, Arizona 85712, United States
GSK Investigational Site, Little Rock, Arkansas 72202, United States
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GSK Investigational Site, Perth, Western Australia, Australia