Epilepsy
Conditions
Keywords
epilepsy, pediatric, partial seizures
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.
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with potentially clinically significant change in vital signs | 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 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) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's assessment of the participant's overall clinical status | Up to 43 months |
| 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 |
Countries
Argentina, Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Puerto Rico, Slovakia, Turkey (Türkiye), United States
Outcome results
None listed