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

Condition(s) targeted: Epilepsy

Intervention: LAMICTAL extended-release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

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

Primary outcome: 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.

Secondary outcome: 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

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

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Starting date: October 2004
Last updated: June 9, 2008