Double‐Blind, Placebo‐Controlled, Lamotrigine in Treatment‐Resistant Generalised Epilepsy

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Abstract
Summary: Purpose: Lamotrigine (LTG) is recognised as effective add‐on therapy for focal epilepsies, but this is the first double‐blind, placebo‐controlled, crossover study in treatmentresistant generalised epilepsy. Methods: The study consisted of 2 × 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 250% 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 250% 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.