Lamotrigine monotherapy for newly diagnosed typical absence seizures in children.
OBJECTIVE
To evaluate the efficacy, tolerability, and effects on behavior and psychosocial functioning of lamotrigine monotherapy in children with newly diagnosed typical absence seizures.


METHODS
Children meeting enrollment criteria (n=54) received a confirmatory 24-h ambulatory electroencephalogram (EEG) and then entered a Escalation Phase of up to 20-weeks during which lamotrigine was titrated until seizures were controlled or maximum dose (10.2mg/kg) was reached. Seizure freedom was assessed by diary review and clinic hyperventilation (clinic HV) and then confirmed by EEG with hyperventilation (HV/EEG). Patients who maintained seizure freedom for two consecutive weekly visits were entered into the Maintenance Phase (n=30). Diary, clinic HV, and HV/EEG data were supplemented with 24-h ambulatory EEG at baseline and the ends of the Escalation and Maintenance Phases. Health outcome assessments were completed at screening and at the end of the Maintenance Phase.


RESULTS
By the end of the Escalation Phase, seizure-free rates (responders) were 59% by seizure diary (n=51), 56% by HV/EEG (n=54) (primary endpoint), and 49% by 24-h ambulatory EEG (n=49). During the Maintenance Phase, 89% (week 24) and 86% (week 32) remained seizure free by diary (n=28), 78% by clinic HV (n=27), and 81% by 24-h ambulatory EEG (n=26). Seizure freedom was first observed beginning at the fifth week of the Escalation Phase. The most frequent adverse events were headache and cough. Health outcome scores were either improved or unchanged at the end of the Maintenance Phase.


CONCLUSIONS
Lamotrigine monotherapy results in complete seizure freedom in a substantial number of children with typical absence seizures. Lamotrigine was well tolerated in this study.
Holmes
Gregory L
GL
Neuroscience Center at Dartmouth, Dartmouth Medical School, Lebanon, NH, USA. Gregory.L.Holmes@dartmouth.edu
Frank
L Matthew
LM
Sheth
Raj D
RD
Philbrook
Bryan
B
Wooten
John D
JD
Vuong
Alain
A
Kerls
Susan
S
Hammer
Anne E
AE
Messenheimer
John
J
D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004569:Electroencephalography / Q000187:drug effects; D004832:Epilepsy, Absence / Q000188:drug therapy*; D005260:Female; D006261:Headache / Q000209:etiology; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008499:Medical Records; D018670:Monitoring, Ambulatory; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine
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