Official Title: “A Multicenter, Double-Blind, Randomized, Parallel-Group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Subjects With Partial Seizures”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: LAMICTAL extended-release

Primary Measures

• The efficacy of LAMICTAL extended-release therapy will be measured by the percentage change from Baseline in partial seizure frequency during the double-blind treatment phase.
  • Time Frame: 24 Weeks
    

Secondary Measures

• Reduction in partial seizure frequency during portions of double-blind phase (=25%,=50%,=75%,100%). Time to 50% reduction in partial seizure frequency. Adverse events. Weight change. Health outcomes questionnaires. Population Pharmacokinetics
  • Time Frame: 24 Weeks
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00113165

Study ID Number: LAM100034

ClinicalTrials.gov Identifier: NCT00113165

Health Authority: United States: Food and Drug Administration