Efficacy & Safety of Zonisamide in newly diagnosed partial epilepsy patients.
A randomized, multi-centre, double-blind study, to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy, in newly diagnosed partial epilepsy
Eisai Ltd
582 participants
Apr 15, 2007
Interventional
Conditions
Summary
In this study the sponsor want to find out if zonisamide can be used on its own to control epilepsy. To find out if zonisamide works on its own, we are comparing it to another drug that we already know works: this drug is called carbamazepine (carb-a-maze-a-peen). We also want to get some more information on the safety of zonisamide.
Eligibility
Inclusion Criteria1
- Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clincially evaluated and calssified partial seizures or generalized tonic-clonic seizures within 12 months of screening.
Exclusion Criteria1
- Subjects have a history of clinical investigations, including EEG data. Subjects with a history of absence, myoclonic, clonic, tonic or atonic seizures, subjects currently taking carbonic anhydrase inhibitors, mono amine oxidase inhibitors.
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Interventions
Zonisamide is the study drug. These will be used as monotherapy in newly diagnosed subjects. the dose will depend on how well the drug controls seizures and how it makes a subject feel. Not everyone in this study will take the same dose of medication. The maximum dose for Zonisamide will be 500mg per day and the minimum dose will be 200mg per day.
Locations(1)
View Full Details on ANZCTR
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ACTRN12607000142437