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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
197
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Time frame: 43 Months
Change from baseline in vital signs -heart rate (HR)
Time frame: Up to 43 Months
Change from baseline in vital signs - weight (WT)
Time frame: Up to 43 months
Change from baseline in vital signs - height (HT)
Time frame: Up to 43 months
Change from baseline in vital signs - head circumference (HC)
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Time frame: Up to month 43
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Time frame: Up to 43 moths
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Time frame: Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Time frame: Up to 43 moths
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GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Jonesboro, Arkansas, 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
Stanford, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Jacksonville, Florida, United States
...and 60 more locations
Change from baseline in Hemoglobin (Hb)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Up to 43 months
Change from baseline in mean corpuscular volume (MCv)
Time frame: Up to 43 months
Change from baseline in red blood cells (RBC)
Time frame: Up to 43 months
Number of participants with treatment emergent neurological abnormalities
Time frame: Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in clinical chemistry parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in vital signs
Time frame: Up to 43 months
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Time frame: Up to 48 Weeks
Investigator's assessment of the participant's overall clinical status
Time frame: Up to 43 months
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Time frame: Week 6