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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAMICTAL extended-release | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17938371 | Background | 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. doi: 10.1212/01.wnl.0000277698.33743.8b. | |
| 29363050 | Derived | van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LAM100034 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 28, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Birmingham |
| Alabama |
| 35294-0021 |
| United States |
| GSK Investigational Site | Northport | Alabama | 35476 | United States |
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| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
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| GSK Investigational Site | Jena | Thuringia | 07743 | Germany |
| GSK Investigational Site | Jena-Lobeda | Thuringia | 07747 | Germany |
| GSK Investigational Site | Hyderabad, Andhra Pradesh | 500482 | India |
| GSK Investigational Site | Lucknow | 226003 | India |
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| GSK Investigational Site | San German | Puerto Rico | 00683 | Puerto Rico |
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| GSK Investigational Site | Moscow | 107076 | Russia |
| GSK Investigational Site | Moscow | 111539 | Russia |
| GSK Investigational Site | Moscow | 117049 | Russia |
| GSK Investigational Site | Moscow | 119334 | Russia |
| GSK Investigational Site | Moscow | 125412 | Russia |
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For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM100034 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 28, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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