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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000142437

Acronym

MAZE

Enrollment

583

Registered

2007-02-23

Start date

2007-04-15

Completion date

2011-01-30

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results