Pediatric Epilepsy Trial in Subjects 1-24 Months

Condition(s) targeted: Epilepsy

Intervention: lamotrigine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Double-Blind, Placebo-Controlled, Add-on Clinical Trial of the Safety, Pharmacokinetics and Efficacy of LAMICTAL in Pediatric Age Subjects (1-24 Months)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase.

Secondary outcome: 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

Minimum age: 1 Month. Maximum age: 24 Months. Gender(s): Both.

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).

GSK Clinical Trials Call Center, Tucson, Arizona 85712, United States

GSK Clinical Trials Call Center, Little Rock, Arkansas 72202, United States

GSK Clinical Trials Call Center, Stanford, California 94305, United States

GSK Clinical Trials Call Center, Los Angeles, California 90027, United States

GSK Clinical Trials Call Center, Los Angeles, California 90095, United States

GSK Clinical Trials Call Center, Denver, Colorado 80218, United States

GSK Clinical Trials Call Center, Washington, District of Columbia 20010, United States

GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States

GSK Clinical Trials Call Center, Miami, Florida 33155, United States

GSK Clinical Trials Call Center, Tampa, Florida 33607, United States

GSK Clinical Trials Call Center, Jacksonville, Florida 32207, United States

GSK Clinical Trials Call Center, Orlando, Florida 32806, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States

GSK Clinical Trials Call Center, Augusta, Georgia 30912, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60637, United States

GSK Clinical Trials Call Center, Lexington, Kentucky 40536, United States

GSK Clinical Trials Call Center, St. Paul, Minnesota 55102, United States

GSK Clinical Trials Call Center, Kansas City, Missouri 64108, United States

GSK Clinical Trials Call Center, Cherry Hill, New Jersey 08034, United States

GSK Clinical Trials Call Center, Syracuse, New York 13210, United States

GSK Clinical Trials Call Center, Rochester, New York 14642, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States

GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States

GSK Clinical Trials Call Center, Akron, Ohio 44308, United States

GSK Clinical Trials Call Center, Columbus, Ohio 43205, United States

GSK Clinical Trials Call Center, Cleveland, Ohio 44106-6090, United States

GSK Clinical Trials Call Center, Portland, Oregon 97201, United States

GSK Clinical Trials Call Center, Portland, Oregon 97201, United States

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15213, United States

GSK Clinical Trials Call Center, Nashville, Tennessee 37212, United States

GSK Clinical Trials Call Center, Dallas, Texas 75230, United States

GSK Clinical Trials Call Center, Fort Worth, Texas 76104, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Charlottesville, Virginia 22908, United States

GSK Clinical Trials Call Center, Richmond, Virginia 23298, United States

Starting date: May 2000
Last updated: June 26, 2007