Dose-dependent safety and efficacy of zonisamide: A randomized, double-blind, placebo-controlled study in patients with refractory partial seizures

Epilepsia

Volumn 46, Issue 1, 2005, Pages 31-41

  Brodie, Martin J ^a,f   Duncan, Roderick ^a   Vespignani, Herve ^b   Solyom, Andras ^c   Bitenskyy, Valeriy ^d   Lucas, Cherry ^e  

^a SOUTHERN GENERAL HOSPITAL   (United Kingdom)

^b UNIVERSITY HOSPITAL OF NANCY   (France)

^c NATIONAL INSTITUTE OF NEUROSURGERY   (Hungary)

^d ODESSA NATIONAL MEDICAL UNIVERSITY   (Ukraine)

^e Elan Pharma Ltd   (United Kingdom)

^f WESTERN INFIRMARY   (United Kingdom)

Author keywords

Adjunctive therapy; Partial seizures; Randomized controlled trial; Refractory epilepsy; Zonisamide

Indexed keywords

ANTIDEPRESSANT AGENT; CARBAMAZEPINE; CLOBAZAM; GABAPENTIN; LAMOTRIGINE; MONOAMINE OXIDASE INHIBITOR; NEUROLEPTIC AGENT; PHENOBARBITAL; PHENYTOIN; PLACEBO; TOPIRAMATE; VALPROIC ACID; ZONISAMIDE;

ADOLESCENT; ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMPLEX PARTIAL SEIZURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOCAL EPILEPSY; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHARYNGITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SOMNOLENCE; TITRIMETRY;

ADOLESCENT; ADULT; AGE FACTORS; AGED; ANTICONVULSANTS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EPILEPSIES, PARTIAL; EPILEPSY, COMPLEX PARTIAL; FEMALE; HEADACHE; HUMANS; ISOXAZOLES; MALE; MIDDLE AGED; PHARYNGITIS; PLACEBOS; SLEEP DISORDERS; TREATMENT OUTCOME;

EID: 13144306049     PISSN: 00139580     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.0013-9580.2005.14704.x     Document Type: Article

References (32)

1. Macdonald RL. Mechanisms of action. In: Levy RH, et al., eds. Antiepileptic drugs. 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2002:867-72.
2. Suzuki S, Kawakami K, Nishimura S, et al. Zonisamide blocks T-type calcium channel in cultured neurons of rat cerebral cortex. Epilepsy Res 1992;12:21-7.
3. Schauf CL. Zonisamide enhances slow sodium inactivation in Myxicola. Brain Res 1987;413:185-8.
4. +, carbamazepine and zonisamide on hippocampal extracellular glutamate monitored with amicrodialysis electrode. Br J Pharmacol 1998;124:1277-85.
5. Zhu W, Rogawski MA. Zonisamide depresses excitatory synaptic transmission by a presynaptic action [Abstract]. Epilepsia 1999;40(suppl 7):245.
6. Kawai M, Hiramatsu M, Endo A, et al. Effect of zonisamide on the release of aspartic acid and gamma-aminobutyric acid from the hippocampal slices of E1 mice. Neurosciences 1994;20:115-9.
7. Jain KK. An assessment of zonisamide as an anti-epileptic drug. Expert Opin Pharmacother 2000;1:1245-60.
8. Seino M, Fujitani B. Clinical efficacy and use in epilepsy. In: Levy RH et al., eds. Antiepileptic drugs. 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2002:885.
9. Schmidt D, Jacob R, Loiseau P, et al. Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial. Epilepsy Res 1993;15:67-73.
10. Sackellares JC, Ramsay RE, Wilder BJ, et al. Randomized, controlled clinical trial of zonisamide as adjunctive treatment for refractory partial seizures. Epilepsia 2004;45:610.
11. Faught E, Ayala R, Montouris GG, et al. Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures. Neurology 2001;57:1774-9.
12. Commission on the Classification and Terminology of the International League Against Epilepsy. Proposal for revised clinical and electroencephalographic classification of epileptic seizures. Epilepsia 1981;22:489-501.
13. Hollander M, Wolfe DA. Nonparametric statistical methods. 1st ed. New York: Wiley, 1973.
14. Marson AG, Kadir ZA, Chadwick DW. New antiepileptic drugs: a systematic review of their efficacy and tolerability. BMJ 1996;313:1169-74.
15. Peeters K, Adriaenssen I, Wapenaar R, et al. A pooled analysis of adjunctive topiramate in refractory partial epilepsy. Acta Neurol Scand 2003;108:9-15.
16. Cereghino JJ, Biton V, Abou-Khalil B, et al. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology 2000;55:236-42.
17. Mohanraj R, Brodie MJ. Measuring the efficacy of antiepileptic drugs. Seizure 2003;12:413-43.
18. Oguni H, Hayashi K, Fukuyama Y, et al. Phase III clinical study of the new antiepileptic drug, AD-810 (zonisamide), in patients with childhood epilepsy. Jpn J Pediatr 1988;42:439-50.
19. Valeriano J, Lane C. Efficacy and tolerability of zonisamide in generalized seizures [Abstract]. Epilepsia 2001;42(suppl 7):188.
20. Suzuki Y, Nagai T, Ono J, et al. Zonisamide monotherapy in newly diagnosed infantile spasms. Epilepsia 1997;38:1035-8.
21. Kishi T, Nejihashi Y, Kajiyama M, et al. Successful zonisamide treatment for infants with hypsarrhythmia. Pediatr Neurol 2000;23:274-7.
22. Kyllerman M, Ben-Menachem E. Zonisamide for progressive myoclonus epilepsy: long-term observations in seven patients. Epilepsy Res 1998;29:109-14.
23. Vossler DG and the Zonisamide PME Study Group. Multicenter, open-label, safety and efficacy study of zonisamide in patients with progressive myoclonic epilepsy [Abstract]. Neurology 2002;58(suppl 3):A296-7.
24. Ganguly G, Selco S, Ko DY. Zonisamide is effective in the treatment of myoclonus status epilepticus and myoclonus in Jakob-Creutzfeldt disease [Abstract]. Epilepsia 2002;43(suppl 7):218.
25. Bourgeois BFD. Zonisamide (ZNS) in the treatment of myoclonic astatic epilepsy (MAE, Doose syndrome) [Abstract]. Epilepsia 2002;43(suppl 7):56.
26. Hershkowitz L. Zonisamide therapy in patients with absence seizures [Abstract]. Epilepsia 2002;43:(suppl 7):193.
27. Kochak GM, Page JG, Buchanan RA, et al. Steady-state pharmacokinetics of zonisamide, an antiepilepsy agent for treatment of refractory complex partial seizures. J Clin Pharmacol 1998;38:166-71.
28. Mather GG, Shah J. Drug interactions. In: Levy RH et al., eds. Antiepileptic drugs. 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2002:880.
29. Rosenfeld WE, Bergen D, Garnett W, et al. Steady-state drug interaction study of zonisamide and carbamazepine in patients with epilepsy [Abstract]. Neurology 2001;56(suppl 3):A336.
30. Levy RH, Ragueneau-Majlessi I, Garnett WR, et al. Lack of a clinically significant effect of zonisamide on phenytoin steady-state pharmacokinetics in patients with epilepsy. J Clin Pharmacol 2004;44:1230-4.
31. Smith D, Brodie M, Dunkley D, et al. Steady-state drug interaction study of zonisamide and sodium valproate in epileptic patients [Abstract]. Neurology 2001;56(suppl 3):A338.
32. Brodie M, Wilson E, Smith D, et al. Steady-state drug interaction study of zonisamide and lamotrigine in epileptic patients [Abstract]. Neurology 2001;56(suppl 3):A337.