Pediatric Epilepsy Study 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 will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

Official title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-Naive Subjects (1-24 Months of Age)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The long-term safety of LAMICTAL will be assessed by adverse events, ECGs, vital signs,and laboratory tests.

Secondary outcome: Effectiveness will be assessed by percent change from baseline in seizure frequency over the course of treatment. Investigators global evaluation of subjects status; standard pharmacokinetics.

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

Criteria:

Inclusion criteria:

- Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for

LAMICTAL naive subjects as follows:

- A confident diagnosis of epilepsy.

- 4 or more partial seizures per month.

- current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria:

- Has seizures not related to epilepsy.

- Has a surgically implanted and functioning vagal nerve stimulator.

- Has previously been treated with lamotrigine.

- Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the

ketogenic diet.

- Use of experimental medication within 30 days of enrollment.

GSK Clinical Trials Call Center, Buenos Aires 1644, Argentina

GSK Clinical Trials Call Center, Tartu 51014, Estonia

GSK Clinical Trials Call Center, Szeged 6701, Hungary

GSK Clinical Trials Call Center, Debrecen 4012, Hungary

GSK Clinical Trials Call Center, Budapest 1094, Hungary

GSK Clinical Trials Call Center, Pecs 7623, Hungary

GSK Clinical Trials Call Center, Riga LV 1004, Latvia

GSK Clinical Trials Call Center, Beirut 113-6044, Lebanon

GSK Clinical Trials Call Center, Kaunas LT-3007, Lithuania

GSK Clinical Trials Call Center, Lisbon 1169-045, Portugal

GSK Clinical Trials Call Center, Coimbra 3000-075, Portugal

GSK Clinical Trials Call Center, Porto 4099-001, Portugal

GSK Clinical Trials Call Center, San Juan 00936, Puerto Rico

GSK Clinical Trials Call Center, Presov 08001, Slovakia

GSK Clinical Trial Call Center, Ankara 06510, Turkey

GSK Clinical Trials Call Center, Mobile, Alabama 36693, United States

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, Jonesboro, Arkansas 72401, United States

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

GSK Clinical Trials Call Center, Stanford, California 94305, 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 32803, 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, Atlanta, Georgia 30342, 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, Columbia, Missouri 65212, 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, Mineola, New York 11501, United States

GSK Clinical Trials Call Center, Buffalo, New York 14222, United States

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

GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, 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, Akron, Ohio 44308, 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, Philadelphia, Pennsylvania 19102, United States

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

GSK Clinical Trials Call Center, Morristown, Tennessee 37813, United States

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

GSK Clinical Trials Call Center, Ft. Worth, Texas 76104, United States

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

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

GSK Clinical Trials Call Center, Salt Lake City, Utah 84108, United States

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

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

GSK Clinical Trials Call Center, Norfolk, Virginia 23507, United States

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