Epilepsy Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures
| Verified date | December 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 244 |
| Est. completion date | July 2007 |
| Est. primary completion date | July 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Capital Federal | Buenos Aires |
| Brazil | GSK Investigational Site | Campinas | São Paulo |
| Brazil | GSK Investigational Site | Curitiba | Paraná |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Germany | GSK Investigational Site | Alzenau | Bayern |
| Germany | GSK Investigational Site | Bad Homburg | Hessen |
| Germany | GSK Investigational Site | Baesweiler | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bamberg | Bayern |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Bernau | Brandenburg |
| Germany | GSK Investigational Site | Bernburg | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Bochum | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bochum | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bueckeburg | Niedersachsen |
| Germany | GSK Investigational Site | Chemnitz | Sachsen |
| Germany | GSK Investigational Site | Essen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Essen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Floeha | Sachsen |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Fuerth | Bayern |
| Germany | GSK Investigational Site | Giessen | Hessen |
| Germany | GSK Investigational Site | Goettingen | Niedersachsen |
| Germany | GSK Investigational Site | Halle | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hattingen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Jena | Thueringen |
| Germany | GSK Investigational Site | Jena-Lobeda | Thueringen |
| Germany | GSK Investigational Site | Kiel | Schleswig-Holstein |
| Germany | GSK Investigational Site | Koeln | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Koeln | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Limburgerhof | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Ludwigsfelde | Brandenburg |
| Germany | GSK Investigational Site | Magdeburg | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Magdeburg | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Moenchengladbach | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Muenster | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Naumburg | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Neuoetting | Bayern |
| Germany | GSK Investigational Site | Osnabrueck | Niedersachsen |
| Germany | GSK Investigational Site | Radeberg | Sachsen |
| Germany | GSK Investigational Site | Singen | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Straubing | Bayern |
| Germany | GSK Investigational Site | Ulm | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Unterhaching | Bayern |
| Germany | GSK Investigational Site | Wismar | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Wismar | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Wuerzburg | Bayern |
| India | GSK Investigational Site | Hyderabad, Andhra Pradesh | |
| India | GSK Investigational Site | Lucknow | |
| India | GSK Investigational Site | New Delhi | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Puerto Rico | GSK Investigational Site | San German | |
| Puerto Rico | GSK Investigational Site | San Juan | |
| Puerto Rico | GSK Investigational Site | San Juan | |
| Russian Federation | GSK Investigational Site | Ekaterinburg | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | St.-Petersburg | |
| Russian Federation | GSK Investigational Site | St.-Petersburg | |
| Ukraine | GSK Investigational Site | Kharkiv | |
| Ukraine | GSK Investigational Site | Kyiv | |
| Ukraine | GSK Investigational Site | Lviv | |
| United States | GSK Investigational Site | Anniston | Alabama |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Augusta | Georgia |
| United States | GSK Investigational Site | Austell | Georgia |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Chesterfield | Missouri |
| United States | GSK Investigational Site | Cheswick | Pennsylvania |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Crestview Hills | Kentucky |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Des Moines | Iowa |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Edison | New Jersey |
| United States | GSK Investigational Site | Flossmoor | Illinois |
| United States | GSK Investigational Site | Galveston | Texas |
| United States | GSK Investigational Site | Grand Rapids | Michigan |
| United States | GSK Investigational Site | Greensburg | Pennsylvania |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Maitland | Florida |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | Northport | Alabama |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Plainview | New York |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | Santa Monica | California |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Sepuldeva | California |
| United States | GSK Investigational Site | Springfield | Illinois |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Sun City | Arizona |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Traverse City | Michigan |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tuscaloosa | Alabama |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | West Orange | New Jersey |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Brazil, Chile, Germany, India, Korea, Republic of, Puerto Rico, Russian Federation, Ukraine,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 24 Weeks | ||
| Secondary | 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 | 24 Weeks |
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