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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Epilepsy, Partial

Intervention: LAMICTAL extended-release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Eligibility

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.

Locations and Contacts

GSK Investigational Site, Berlin 10969, Germany

GSK Investigational Site, Hamburg 22083, Germany

GSK Investigational Site, Hamburg 22523, Germany

GSK Investigational Site, Hamburg 22527, Germany

GSK Investigational Site, Hyderabad, Andhra Pradesh 500482, India

GSK Investigational Site, Lucknow 226003, India

GSK Investigational Site, New Delhi, India

GSK Investigational Site, Seoul 138-736, Korea, Republic of

GSK Investigational Site, San German 00683, Puerto Rico

GSK Investigational Site, San Juan 00918, Puerto Rico

GSK Investigational Site, Ekaterinburg 620102, Russian Federation

GSK Investigational Site, Moscow 107076, Russian Federation

GSK Investigational Site, Moscow 111539, Russian Federation

GSK Investigational Site, Moscow 117049, Russian Federation

GSK Investigational Site, Moscow 125412, Russian Federation

GSK Investigational Site, Moscow 127473, Russian Federation

GSK Investigational Site, St.-Petersburg 193019, Russian Federation

GSK Investigational Site, St.-Petersburg 197376, Russian Federation

GSK Investigational Site, Kharkiv 61068, Ukraine

GSK Investigational Site, Kyiv 02660, Ukraine

GSK Investigational Site, Lviv 79021, Ukraine

GSK Investigational Site, Anniston, Alabama 36207, United States

GSK Investigational Site, Birmingham, Alabama 35294-0021, United States

GSK Investigational Site, Northport, Alabama 35476, United States

GSK Investigational Site, Mesa, Arizona 85201, United States

GSK Investigational Site, Sun City, Arizona 85351, United States

GSK Investigational Site, Tucson, Arizona 85712, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Alzenau, Bayern 63755, Germany

GSK Investigational Site, Fuerth, Bayern 90762, Germany

GSK Investigational Site, Ludwigsfelde, Brandenburg 14974, Germany

GSK Investigational Site, Capital Federal, Buenos Aires 1181, Argentina

GSK Investigational Site, Los Angeles, California 90033, United States

GSK Investigational Site, Los Angeles, California 90073, United States

GSK Investigational Site, Newport Beach, California 92660, United States

GSK Investigational Site, Santa Monica, California 90404, United States

GSK Investigational Site, Washington, District of Columbia 20037, United States

GSK Investigational Site, Ocala, Florida 34471, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Bad Homburg, Hessen 61348, Germany

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Flossmoor, Illinois 60422, United States

GSK Investigational Site, Springfield, Illinois 62702, United States

GSK Investigational Site, Wichita, Kansas 67214, United States

GSK Investigational Site, Crestview Hills, Kentucky 41017, United States

GSK Investigational Site, Lexington, Kentucky 40536-0284, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Boston, Massachusetts 02118, United States

GSK Investigational Site, Boston, Massachusetts 02215, United States

GSK Investigational Site, Wismar, Mecklenburg-Vorpommern 23970, Germany

GSK Investigational Site, Detroit, Michigan 48202, United States

GSK Investigational Site, Traverse City, Michigan 49684, United States

GSK Investigational Site, Minneapolis, Minnesota 55422, United States

GSK Investigational Site, Minneapolis, Minnesota 55454, United States

GSK Investigational Site, Chesterfield, Missouri 63017, United States

GSK Investigational Site, Kansas City, Missouri 64111, United States

GSK Investigational Site, St. Louis, Missouri 63110, United States

GSK Investigational Site, Las Vegas, Nevada 89103, United States

GSK Investigational Site, Koeln, Nordrhein-Westfalen 50672, Germany

GSK Investigational Site, Koeln, Nordrhein-Westfalen 50767, Germany

GSK Investigational Site, Muenster, Nordrhein-Westfalen 48149, Germany

GSK Investigational Site, Asheville, North Carolina 28801, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Columbus, Ohio 43210-1250, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Curitiba, Paraná 80069-900, Brazil

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, Santiago, Región Metro De Santiago, Chile

GSK Investigational Site, Santiago, Región Metro De Santiago 7571831, Chile

GSK Investigational Site, Limburgerhof, Rheinland-Pfalz 67117, Germany

GSK Investigational Site, Leipzig, Sachsen 04105, Germany

GSK Investigational Site, Radeberg, Sachsen 01465, Germany

GSK Investigational Site, Naumburg, Sachsen-Anhalt 06618, Germany

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Dallas, Texas 75235, United States

GSK Investigational Site, Galveston, Texas 77555, United States

GSK Investigational Site, Houston, Texas 77005, United States

GSK Investigational Site, Wichita Falls, Texas 76301, United States

GSK Investigational Site, Jena-Lobeda, Thueringen 07747, Germany

GSK Investigational Site, Richmond, Virginia 23220, United States

GSK Investigational Site, Seattle, Washington 98122-4358, United States

Additional Information

Related publications:

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.

Starting date: October 2004
Last updated: April 14, 2015

Page last updated: August 23, 2015

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