Double-blind, placebo-controlled, crossover study of lamotrigine in treatment-resistant generalised epilepsy.
OBJECTIVE
Lamotrigine (LTG) is recognised as effective add-on therapy for focal epilepsies, but this is the first double-blind, placebo-controlled, crossover study in treatment-resistant generalised epilepsy.


METHODS
The study consisted of 2 x 8-week treatment periods followed by a 4-week washout period. Patients received doses of either 75 or 150 mg daily, depending on their concomitant antiepileptic drugs (AEDs). Long-term continuation was offered at the end of the study with open-label LTG.


RESULTS
Five centres in Australia recruited 26 patients who were having absence, myoclonic, or generalized tonic-clonic seizures or a combination of these. Twenty-two patients completed the study. There was a significant reduction in frequency of both tonic-clonic and absence seizure types with LTG. A 350% decrease in seizures was observed for tonic-clonic seizures in 50% of cases and for absence seizures in 33% of evaluable cases. Rash was the only adverse effect causing discontinuation. Twenty-three of 26 opted for open-label LTG, with 20 still receiving LTG for a mean of 26 months. In these 20, 80% had > or =50% seizure reduction and five (25%) were seizure free.


CONCLUSIONS
This study shows that LTG is effective add-on therapy in patients with refractory generalised epilepsies. Statistically significant reduction in seizures in both absence and tonic-clonic seizure types was seen even with low doses of LTG.
Beran
R G
RG
Liverpool Hospital, New South Wales, Australia.
Berkovic
S F
SF
Dunagan
F M
FM
Vajda
F J
FJ
Danta
G
G
Black
A B
AB
Mackenzie
R
R
D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004829:Epilepsy, Generalized / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000627:therapeutic use*
D000927:Anticonvulsants; D010919:Placebos; D014227:Triazines; D000077213:Lamotrigine