Pediatric Epilepsy Trial in Subjects 1-24 Months

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00043875

Run by

GlaxoSmithKline

People needed

177

Starts

2000-05-01

Expected to finish

2003-11-01

Last updated by the study team

2016-09-15

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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).

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Cherry Hill, New Jersey, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Akron, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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