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A superiority, randomized, open-label, multi-center study to compare the efficacy and safety of adjunctive zonisamide vs replacement with zonisamide of the last added antiepileptic drug in patients wi...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-010895-64

A superiority, randomized, open-label, multi-center study to compare the efficacy and safety of adjunctive zonisamide vs replacement with zonisamide of the last added antiepileptic drug in patients with partial onset seizures

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Extrait

The primary objective of this study is to assess, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the safety and efficacy of the triple therapy vs the double therapy.

Critère d'inclusion

  • Patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven’t obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months

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