Pediatric Epilepsy Study in Subjects 1-24 Months
Phase 2
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00044278
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 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 clinical chemistry parameters including Albumin and Total protein Up to month 43 Change from baseline in Hemoglobin (Hb) 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 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 Mean corpuscular hemoglobin (MCH) 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 vital signs Up to 43 months 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 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 Mean corpuscular hemoglobin concentration (MCHC) Up to 43 months Number of participants with treatment emergent neurological abnormalities Up to 43 months Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC) Up to 43 moths 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 hematology parameters Up to 43 months
- Secondary Outcome Measures
Name Time Method Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants Week 6 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇹🇷Ankara, Turkey