Pediatric Epilepsy Study in Subjects 1-24 Months

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00044278

Run by

GlaxoSmithKline

People needed

197

Starts

2000-09-01

Expected to finish

2006-06-01

Last updated by the study team

2017-01-18

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• 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 — Columbia, Missouri, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Cherry Hill, New Jersey, United States
• GSK Investigational Site — Buffalo, New York, United States
• GSK Investigational Site — Mineola, New York, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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