CompletedPhase 3ACTRN12607000142437

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

Sponsor

Eisai Ltd

Enrollment

582 participants

Start Date

Apr 15, 2007

Study Type

Interventional

Conditions

Newly diagnosed partial epilepsy

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether zonisamide is effective and safe as the first treatment for newly diagnosed epilepsy. It is for adults aged 18 to 75 who have had at least two confirmed partial or generalized tonic-clonic seizures within the past 12 months and have not yet started epilepsy medication. Participants must not have other seizure types like absence or myoclonic seizures.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

NSW,QLD,SA,VIC, Australia

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ACTRN12607000142437