Pediatric Epilepsy Trial in Subjects 1-24 Months

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Drug: lamotrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043875

LAM20006

Details and patient eligibility

About

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.

Enrollment

177 patients

Sex

All

Ages

1 to 24 months old

Volunteers

No Healthy Volunteers

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).