Epilepsy Clinical Trial
Official title:
An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)
Verified date | January 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 197 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 24 Months |
Eligibility |
Inclusion criteria: - Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows: - A confident diagnosis of epilepsy. - 4 or more partial seizures per month. - current treatment with 1 or 2 anti-epileptic drugs. Exclusion criteria: - Has seizures not related to epilepsy. - Has a surgically implanted and functioning vagal nerve stimulator. - Has previously been treated with lamotrigine. - Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet. - Use of experimental medication within 30 days of enrollment. |
Country | Name | City | State |
---|---|---|---|
Argentina | GSK Investigational Site | Capital Federal | Buenos Aires |
Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
Australia | GSK Investigational Site | Parkville, Melbourne | Victoria |
Estonia | GSK Investigational Site | Tartu | |
France | GSK Investigational Site | Reims Cedex | |
Hungary | GSK Investigational Site | Budapest | |
Hungary | GSK Investigational Site | Debrecen | |
Hungary | GSK Investigational Site | Miskolc | |
Hungary | GSK Investigational Site | Pécs | |
Hungary | GSK Investigational Site | Szeged | |
Italy | GSK Investigational Site | Bologna | Emilia-Romagna |
Italy | GSK Investigational Site | Mantova | Lombardia |
Italy | GSK Investigational Site | Messina | Sicilia |
Italy | GSK Investigational Site | Milano | Lombardia |
Italy | GSK Investigational Site | Napoli | Campania |
Italy | GSK Investigational Site | Padova | Veneto |
Latvia | GSK Investigational Site | Riga | |
Lebanon | GSK Investigational Site | Beirut | |
Lithuania | GSK Investigational Site | Kaunas | |
Netherlands | GSK Investigational Site | Groningen | |
Netherlands | GSK Investigational Site | Rotterdam | |
Netherlands | GSK Investigational Site | Utrecht | |
Portugal | GSK Investigational Site | Coimbra | |
Portugal | GSK Investigational Site | Lisboa | |
Portugal | GSK Investigational Site | Porto | |
Puerto Rico | GSK Investigational Site | SanJuan | |
Slovakia | GSK Investigational Site | Bratislava | |
Slovakia | GSK Investigational Site | Presov | |
Turkey | GSK Investigational Site | Ankara | |
United States | GSK Investigational Site | Akron | Ohio |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Augusta | Georgia |
United States | GSK Investigational Site | Buffalo | New York |
United States | GSK Investigational Site | Chapel Hill | North Carolina |
United States | GSK Investigational Site | Charlottesville | Virginia |
United States | GSK Investigational Site | Cherry Hill | New Jersey |
United States | GSK Investigational Site | Cleveland | Ohio |
United States | GSK Investigational Site | Columbia | Missouri |
United States | GSK Investigational Site | Columbus | Ohio |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Fort Worth | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Jacksonville | Florida |
United States | GSK Investigational Site | Jonesboro | Arkansas |
United States | GSK Investigational Site | Kansas City | Missouri |
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 | Miami | Florida |
United States | GSK Investigational Site | Mineola | New York |
United States | GSK Investigational Site | Mobile | Alabama |
United States | GSK Investigational Site | Morristown | Tennessee |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | Norfolk | Virginia |
United States | GSK Investigational Site | Orlando | Florida |
United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
United States | GSK Investigational Site | Portland | Oregon |
United States | GSK Investigational Site | Portland | Oregon |
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 | St. Paul | Minnesota |
United States | GSK Investigational Site | Stanford | California |
United States | GSK Investigational Site | Syracuse | New York |
United States | GSK Investigational Site | Tallahassee | Florida |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | Tucson | Arizona |
United States | GSK Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Argentina, Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Puerto Rico, Slovakia, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation | 43 Months | ||
Primary | Change from baseline in vital signs -heart rate (HR) | Up to 43 Months | ||
Primary | Change from baseline in vital signs - weight (WT) | Up to 43 months | ||
Primary | Change from baseline in vital signs - height (HT) | Up to 43 months | ||
Primary | Change from baseline in vital signs - head circumference (HC) | Up to 43 months | ||
Primary | Change from baseline in clinical chemistry parameters including Albumin and Total protein | Up to month 43 | ||
Primary | Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST) | Up to 43 moths | ||
Primary | Change from baseline in clinical chemistry parameters including total bilirubin and creatinine | Up to 43 months | ||
Primary | Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea | Up to 43 months | ||
Primary | Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC) | Up to 43 moths | ||
Primary | Change from baseline in Hemoglobin (Hb) | Up to 43 months | ||
Primary | Change from baseline in Mean corpuscular hemoglobin (MCH) | Up to 43 months | ||
Primary | Change from baseline in Mean corpuscular hemoglobin concentration (MCHC) | Up to 43 months | ||
Primary | Change from baseline in mean corpuscular volume (MCv) | Up to 43 months | ||
Primary | Change from baseline in red blood cells (RBC) | Up to 43 months | ||
Primary | Number of participants with treatment emergent neurological abnormalities | Up to 43 months | ||
Primary | Number of participants with treatment emergent clinically significant ECG abnormalities | Up to 43 months | ||
Primary | Number of participants with potentially clinically significant change in hematology parameters | Up to 43 months | ||
Primary | Number of participants with potentially clinically significant change in clinical chemistry parameters | Up to 43 months | ||
Primary | Number of participants with potentially clinically significant change in vital signs | Up to 43 months | ||
Secondary | 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 | ||
Secondary | Investigator's assessment of the participant's overall clinical status | Up to 43 months | ||
Secondary | Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants | Week 6 |
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