Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: LAMICTAL extended-release
Outcome Measures for this Clinical Trial
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
- 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
- Time Frame: 24 Weeks
Criteria for Participation 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 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
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Related Publications
References
Erratum: Lamotrigine extended-release as adjunctive therapy for partial seizures. Neurology 2009;72;201
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00113165
Study ID Number: LAM100034
ClinicalTrials.gov Identifier: NCT00113165
Health Authority: India: Indian Council of Medical Research
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00113165
