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

  1. R. G. Beran1,*,
  2. S. F. Berkovic2,
  3. F. M. Dunagan6,
  4. F. J. E. Vajda1,
  5. G. Danta3,
  6. A. B. Black4,
  7. R. Mackenzie5

Article first published online: 3 AUG 2005

DOI: 10.1111/j.1528-1157.1998.tb01332.x

Issue

Epilepsia

Epilepsia

Volume 39, Issue 12, pages 1329–1333, December 1998

Additional Information

How to Cite

Beran, R. G., Berkovic, S. F., Dunagan, F. M., Vajda, F. J. E., Danta, G., Black, A. B. and Mackenzie, R. (1998), Double-Blind, Placebo-Controlled, Lamotrigine in Treatment-Resistant Generalised Epilepsy. Epilepsia, 39: 1329–1333. doi: 10.1111/j.1528-1157.1998.tb01332.x

Author Information

  1. 1

    Liverpool Hospital, Liverpool, New South Wales

  2. 2

    Austin and Repatriation Medical Centre, Heidelberg, Victoria

  3. 3

    Woden Valley Hospital, Garran, Australian Capital Territory

  4. 4

    Queen Elizabeth Hospital, Woodville, South Australia

  5. 5

    Prince Henry Hospital, Little Bay, New South Wales

  6. 6

    Glaxo Wellcome Australia Ltd., Boronia, Victoria, Australia

*Address correspondence and reprint requests to Dr. R. G. Beran at Of Lennox-Gastaut syndrome were 6th Floor, 12 Thomas Street, Chatswood NSW 2067, Australia.

Publication History

  1. Issue published online: 3 AUG 2005
  2. Article first published online: 3 AUG 2005
  3. Accepted June 9, 1998.

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Keywords:

  • Lamotrigine;
  • Epilepsy;
  • Generalized seizures;
  • Double;
  • blind clinical trial

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.

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