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This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of LAMICTAL add-on therapy will be measured by the proportion of subjects who meet escape criteria during the Double-Blind Phase. | 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to escape patterns in Double-Blind phase. Reduction in partial seizure frequency at end of Open-Label Phase. Investigators' global evaluation of subjects' status at end of Open-Label and Double-Blind Phases; Standard pharmacokinetics; Adverse Events | 36 Months |
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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 | Tucson | Arizona | 85712 | United States | ||
| GSK Investigational Site |
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| 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 |
|---|---|---|---|
| LAM20006 | Clinical Study Report | 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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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90027 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Stanford | California | 94305-5235 | United States |
| GSK Investigational Site | Denver | Colorado | 80218 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Miami | Florida | 33155-3009 | United States |
| GSK Investigational Site | Orlando | Florida | 32835 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Tampa | Florida | 33607-6350 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Augusta | Georgia | 30912 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536-0284 | United States |
| GSK Investigational Site | Saint Paul | Minnesota | 55102-2383 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | Cherry Hill | New Jersey | 8034 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Akron | Ohio | 44308-1062 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Columbus | Ohio | 43205 | United States |
| GSK Investigational Site | Portland | Oregon | 97227 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213-2583 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37212 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23510 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | South Brisbane | Queensland | 4101 | Australia |
| GSK Investigational Site | Parkville, Melbourne | Victoria | 3050 | Australia |
| GSK Investigational Site | West Heidleberg, Melbourne | Victoria | Australia |
| GSK Investigational Site | Perth | Western Australia | Australia |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Reims | 51092 | France |
| GSK Investigational Site | Budapest | 1094 | Hungary |
| GSK Investigational Site | Debrecen | 4012 | Hungary |
| GSK Investigational Site | Miskolc | 3526 | Hungary |
| GSK Investigational Site | Szeged | 6720 | Hungary |
| GSK Investigational Site | Naples | Campania | 80131 | Italy |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40138 | Italy |
| GSK Investigational Site | Mantua | Lombardy | 46100 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20133 | Italy |
| GSK Investigational Site | Messina | Sicily | 98125 | Italy |
| GSK Investigational Site | Padova | Veneto | 35128 | Italy |
| GSK Investigational Site | Riga | LV 1004 | Latvia |
| GSK Investigational Site | Beirut | 11072020 | Lebanon |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Groningen | 9713 GZ | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GD | Netherlands |
| GSK Investigational Site | Utrecht | 3584 EA | Netherlands |
| GSK Investigational Site | Coimbra | 3000-075 | Portugal |
| GSK Investigational Site | Lisbon | 1150 | Portugal |
| GSK Investigational Site | Porto | 4099-001 | Portugal |
| GSK Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| GSK Investigational Site | Bratislava | 833 40 | Slovakia |
| GSK Investigational Site | Prešov | 080 01 | Slovakia |
| GSK Investigational Site | Las Palmas de Gran Canaria | 35016 | Spain |
| GSK Investigational Site | Ankara | Turkey (Türkiye) |
For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20006 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| 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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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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