Pediatric Epilepsy Trial in Subjects 1-24 Months

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

Criteria

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).