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

Overview

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.

Full Title of Study: “A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: July 2007

Interventions

  • Drug: LAMICTAL extended-release

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 13 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

Naritoku DK, Warnock CR, Messenheimer JA, Borgohain R, Evers S, Guekht AB, Karlov VA, Lee BI, Pohl LR. Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology. 2007 Oct 16;69(16):1610-8. Erratum in: Neurology. 2009 Jan 13;72(2):201.

Erratum: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2009;72;201

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