Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Epilepsy Epilepsy, Partial |
| Intervention | Drug: LAMICTAL extended-release |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00113165 |
| First Received | June 6, 2005 |
| Last Updated | June 14, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 6, 2005 |
|---|---|
| Last Updated Date | June 14, 2012 |
| Start Date | October 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome 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] |
| Current Secondary Outcome 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Partial Seizures |
|---|---|
| Official Title | A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Partial Seizures |
| Brief 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: LAMICTAL extended-release Other Names: LAMICTAL extended-release |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 204 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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. |
| Gender | Both |
| Ages | 13 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Brazil, Chile, Germany, India, Korea, Republic of, Puerto Rico, Russian Federation, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00113165 |
|---|---|
| Other Study ID Numbers | LAM100034 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Anniston, Alabama, United States, 36207 |
|---|---|
| GSK Investigational Site | Birmingham, Alabama, United States, 35294-0021 |
| GSK Investigational Site | Northport, Alabama, United States, 35476 |
| GSK Investigational Site | Mesa, Arizona, United States, 85201 |
| GSK Investigational Site | Sun City, Arizona, United States, 85351 |
| GSK Investigational Site | Tucson, Arizona, United States, 85712 |
| GSK Investigational Site | Little Rock, Arkansas, United States, 72205 |
| GSK Investigational Site | Los Angeles, California, United States, 90033 |
| GSK Investigational Site | Los Angeles, California, United States, 90073 |
| GSK Investigational Site | Newport Beach, California, United States, 92660 |
| GSK Investigational Site | Santa Monica, California, United States, 90404 |
| GSK Investigational Site | Washington, District of Columbia, United States, 20037 |
| GSK Investigational Site | Ocala, Florida, United States, 34471 |
| GSK Investigational Site | Tallahassee, Florida, United States, 32308 |
| GSK Investigational Site | Atlanta, Georgia, United States, 30342 |
| GSK Investigational Site | Chicago, Illinois, United States, 60612 |
| GSK Investigational Site | Flossmoor, Illinois, United States, 60422 |
| GSK Investigational Site | Springfield, Illinois, United States, 62702 |
| GSK Investigational Site | Wichita, Kansas, United States, 67214 |
| GSK Investigational Site | Crestview Hills, Kentucky, United States, 41017 |
| GSK Investigational Site | Lexington, Kentucky, United States, 40536-0284 |
| GSK Investigational Site | Louisville, Kentucky, United States, 40202 |
| GSK Investigational Site | Boston, Massachusetts, United States, 02215 |
| GSK Investigational Site | Boston, Massachusetts, United States, 02118 |
| GSK Investigational Site | Detroit, Michigan, United States, 48202 |
| GSK Investigational Site | Traverse City, Michigan, United States, 49684 |
| GSK Investigational Site | Minneapolis, Minnesota, United States, 55422 |
| GSK Investigational Site | Minneapolis, Minnesota, United States, 55454 |
| GSK Investigational Site | Chesterfield, Missouri, United States, 63017 |
| GSK Investigational Site | Kansas City, Missouri, United States, 64111 |
| GSK Investigational Site | St. Louis, Missouri, United States, 63110 |
| GSK Investigational Site | Las Vegas, Nevada, United States, 89103 |
| GSK Investigational Site | Asheville, North Carolina, United States, 28801 |
| GSK Investigational Site | Raleigh, North Carolina, United States, 27607 |
| GSK Investigational Site | Columbus, Ohio, United States, 43210-1250 |
| GSK Investigational Site | Oklahoma City, Oklahoma, United States, 73112 |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States, 19107 |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States, 19140 |
| GSK Investigational Site | Dallas, Texas, United States, 75230 |
| GSK Investigational Site | Dallas, Texas, United States, 75235 |
| GSK Investigational Site | Galveston, Texas, United States, 77555 |
| GSK Investigational Site | Houston, Texas, United States, 77005 |
| GSK Investigational Site | Wichita Falls, Texas, United States, 76301 |
| GSK Investigational Site | Richmond, Virginia, United States, 23220 |
| GSK Investigational Site | Seattle, Washington, United States, 98122-4358 |
| GSK Investigational Site | Capital Federal, Buenos Aires, Argentina, 1181 |
| GSK Investigational Site | Curitiba, Paraná, Brazil, 80069-900 |
| GSK Investigational Site | Santiago, Región Metro De Santiago, Chile, 7571831 |
| GSK Investigational Site | Santiago, Región Metro De Santiago, Chile |
| GSK Investigational Site | Alzenau, Bayern, Germany, 63755 |
| GSK Investigational Site | Fuerth, Bayern, Germany, 90762 |
| GSK Investigational Site | Ludwigsfelde, Brandenburg, Germany, 14974 |
| GSK Investigational Site | Bad Homburg, Hessen, Germany, 61348 |
| GSK Investigational Site | Wismar, Mecklenburg-Vorpommern, Germany, 23970 |
| GSK Investigational Site | Koeln, Nordrhein-Westfalen, Germany, 50767 |
| GSK Investigational Site | Koeln, Nordrhein-Westfalen, Germany, 50672 |
| GSK Investigational Site | Muenster, Nordrhein-Westfalen, Germany, 48149 |
| GSK Investigational Site | Limburgerhof, Rheinland-Pfalz, Germany, 67117 |
| GSK Investigational Site | Naumburg, Sachsen-Anhalt, Germany, 06618 |
| GSK Investigational Site | Leipzig, Sachsen, Germany, 04105 |
| GSK Investigational Site | Radeberg, Sachsen, Germany, 01465 |
| GSK Investigational Site | Jena-Lobeda, Thueringen, Germany, 07747 |
| GSK Investigational Site | Berlin, Germany, 10969 |
| GSK Investigational Site | Hamburg, Germany, 22523 |
| GSK Investigational Site | Hamburg, Germany, 22083 |
| GSK Investigational Site | Hamburg, Germany, 22527 |
| GSK Investigational Site | Hyderabad, Andhra Pradesh, India, 500482 |
| GSK Investigational Site | Lucknow, India, 226003 |
| GSK Investigational Site | New Delhi, India |
| GSK Investigational Site | Seoul, Korea, Republic of, 138-736 |
| GSK Investigational Site | San German, Puerto Rico, 00683 |
| GSK Investigational Site | San Juan, Puerto Rico, 00918 |
| GSK Investigational Site | Ekaterinburg, Russian Federation, 620102 |
| GSK Investigational Site | Moscow, Russian Federation, 111539 |
| GSK Investigational Site | Moscow, Russian Federation, 127473 |
| GSK Investigational Site | Moscow, Russian Federation, 117049 |
| GSK Investigational Site | Moscow, Russian Federation, 107076 |
| GSK Investigational Site | Moscow, Russian Federation, 125412 |
| GSK Investigational Site | St.-Petersburg, Russian Federation, 197376 |
| GSK Investigational Site | St.-Petersburg, Russian Federation, 193019 |
| GSK Investigational Site | Kharkiv, Ukraine, 61068 |
| GSK Investigational Site | Kyiv, Ukraine, 02660 |
| GSK Investigational Site | Lviv, Ukraine, 79021 |