Lamictal (lamotrigine) monotherapy for typical absence seizures in children.
OBJECTIVE
To investigate whether lamotrigine (LTG) monotherapy is effective and safe for newly diagnosed typical absence seizures in children and adolescents (aged 3-15 years, n = 45).


METHODS
A "responder-enriched" study design was used: open-label dose escalation was followed by placebo-controlled, double-blind testing of LTG. Conventional hyperventilation testing with EEG recording was used to confirm diagnoses and assess treatment success defined as complete freedom from seizures. Ambulatory 24-h EEG recordings provided supporting evidence of effectiveness. Safety was assessed by evaluation of adverse events, vital signs, and physical, neurologic, and laboratory examinations. Plasma samples were taken to evaluate the pharmacokinetics of LTG.


RESULTS
During initial open-label dose escalation, 71.4% of patients (intent-to-treat) or 82% (per protocol analysis) became seizure free; individual patients responded at doses ranging from 2 to 15 mg/kg/day (median, 5.0). In the placebo-controlled, double-blind phase of the study, statistically significantly more patients remained seizure free when treated with LTG (62%) than with placebo (21%; p < 0.02; for the intent-to-treat analysis). Mean plasma concentrations of LTG, were linearly related to dose, although there was substantial interindividual variation. No patients were withdrawn from the study for any safety-related reason.


CONCLUSIONS
LTG monotherapy is effective for typical absence seizures in children and is generally well tolerated.
Neurodevelomental Center of The Children's Hospital of The King's Daughters and Eastern Virginia Medical School, Norfolk 23510, USA.
L M
LM
Frank
T
T
Enlow
G L
GL
Holmes
P
P
Manasco
S
S
Concannon
C
C
Chen
G
G
Womble
E J
EJ
Casale
D000293:Adolescent; D000367:Age Factors; D000927:Anticonvulsants / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D001827:Body Height; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004569:Electroencephalography / Q000379:methods; D004832:Epilepsy, Absence / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D018670:Monitoring, Ambulatory; D010919:Placebos; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*
D000927:Anticonvulsants; D010919:Placebos; D014227:Triazines; D000077213:Lamotrigine