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This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation | 43 Months | |
| Change from baseline in vital signs -heart rate (HR) | Up to 43 Months | |
| Change from baseline in vital signs - weight (WT) | Up to 43 months | |
| Change from baseline in vital signs - height (HT) | Up to 43 months | |
| Change from baseline in vital signs - head circumference (HC) | Up to 43 months | |
| Change from baseline in clinical chemistry parameters including Albumin and Total protein | Up to month 43 | |
| Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST) | Up to 43 moths | |
| Change from baseline in clinical chemistry parameters including total bilirubin and creatinine | Up to 43 months | |
| Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea | Up to 43 months | |
| Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase | Up to 48 Weeks | |
| Investigator's assessment of the participant's overall clinical status | Up to 43 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 | Mobile | Alabama | 36693 | 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 |
|---|---|---|---|
| LAM20007 | Annotated Case Report Form | 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 22, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Up to 43 moths |
| Change from baseline in Hemoglobin (Hb) | Up to 43 months |
| Change from baseline in Mean corpuscular hemoglobin (MCH) | Up to 43 months |
| Change from baseline in Mean corpuscular hemoglobin concentration (MCHC) | Up to 43 months |
| Change from baseline in mean corpuscular volume (MCv) | Up to 43 months |
| Change from baseline in red blood cells (RBC) | Up to 43 months |
| Number of participants with treatment emergent neurological abnormalities | Up to 43 months |
| Number of participants with treatment emergent clinically significant ECG abnormalities | Up to 43 months |
| Number of participants with potentially clinically significant change in hematology parameters | Up to 43 months |
| Number of participants with potentially clinically significant change in clinical chemistry parameters | Up to 43 months |
| Number of participants with potentially clinically significant change in vital signs | Up to 43 months |
| Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants | Week 6 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | 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 | 33609 | 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 | Columbia | Missouri | 65211 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | Cherry Hill | New Jersey | 8034 | United States |
| GSK Investigational Site | Buffalo | New York | 14222 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | 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 | 97201-2884 | United States |
| GSK Investigational Site | Portland | Oregon | 97201-2984 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213-2583 | United States |
| GSK Investigational Site | Morristown | Tennessee | 37813 | 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 | Salt Lake City | Utah | 84113 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | Capital Federal | Buenos Aires | 1181 | Argentina |
| GSK Investigational Site | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Parkville, Melbourne | Victoria | 3050 | Australia |
| 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 | Pécs | 7623 | 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 | SanJuan | Puerto Rico | 00936 | Puerto Rico |
| GSK Investigational Site | Bratislava | 833 40 | Slovakia |
| GSK Investigational Site | Prešov | 080 01 | Slovakia |
| GSK Investigational Site | Ankara | Turkey (Türkiye) |
For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LAM20007 | Individual Participant Data Set | 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 22, 2017 | Aug 15, 2018 |
| 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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