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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.