Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures

Completed · Phase 3

Conditions studied: Epilepsy, Epilepsy, Partial

In brief

This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Key facts

Study ID

NCT00113165

Run by

GlaxoSmithKline

People needed

244

Starts

2004-10-01

Expected to finish

2007-07-01

Last updated by the study team

2016-12-05

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of epilepsy with partial seizures for more than 24 weeks.
• Must experience at least 8 partial seizures during an 8-week Baseline Phase.
• Must currently be receiving treatment with a stable regimen of one or two antiepileptic drugs for at least four weeks.
• Patient or parent/caregiver must be willing and able to maintain a written daily seizure diary.

You may not qualify if…

• Previous treatment with lamotrigine.
• Exhibits any primary generalized seizures.
• Receiving treatment with felbamate or currently following the ketogenic diet.
• Pregnant, breastfeeding, or planning to become pregnant.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Northport, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Sun City, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, 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 — Newport Beach, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Sepuldeva, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Maitland, Florida, United States
• GSK Investigational Site — Ocala, 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 — Austell, Georgia, United States
• GSK Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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