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Trial registered on ANZCTR
Registration number
ACTRN12607000142437
Ethics application status
Not yet submitted
Date submitted
1/02/2007
Date registered
23/02/2007
Date last updated
20/09/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy & Safety of Zonisamide in newly diagnosed partial epilepsy patients.
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Scientific title
A randomized, multi-centre, double-blind study, to compare the efficacy and safety of zonisamide and carbamazepine as monotherapy, in newly diagnosed partial epilepsy
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Secondary ID [1]
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Eisai Ltd: E2090-E044-310
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Universal Trial Number (UTN)
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Trial acronym
MAZE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Newly diagnosed partial epilepsy
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Condition category
Condition code
Neurological
1744
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Epilepsy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
1582
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Diagnosis / Prognosis
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Comparator / control treatment
Comparator is carbamazepine. 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 Carbamazepine will be 1200 mg per day and the minimum dose will be 400mg per day till they get a seizure
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of subjects remaining seizure free for at least a 26 week period when treated with zonisamide or carbamazepine as compared to baseline.
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Assessment method [1]
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Timepoint [1]
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Seizure diary will be measured at every visit from week 1 to week 56
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Secondary outcome [1]
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Proportion of subjects seizure free for 52 weeks.
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Assessment method [1]
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Timepoint [1]
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Seizure diary will be reviewed at every Visit from week 3 to between week 31 to week 103. Time to withdrawal due to lack of efficacy/due to an Adverse Events from week 3 to between week 31 to 109. Time to the start of a 26 weeks and 52 week seizure free period. For this the seizure diary will be measured between week 31 and 109 and at week 109.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by site (using permuted blocks within site)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
In this study a subject, an investigator and a sponsor will keep blinded
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/04/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
582
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Pharmaceutical Research Associate Ltd.
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Address [1]
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Country [1]
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Primary sponsor type
Commercial sector/Industry
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Name
Eisai Ltd
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Address
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Country
United Kingdom
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Pharmaceutical Research Associate Ltd.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Flinders Medical Centre
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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Ethics approval number [1]
3519
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nimisha Katariya
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Address
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PRA International
Level 17 Suite 1701
323 Castlereagh Street
Sydney NSW 2000
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Country
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Australia
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Phone
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+61 2 92898542
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Fax
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+61 2 92811982
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nimisha Katariya
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Address
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PRA International
Level 17 Suite 1701
323 Castlereagh Street
Sydney NSW 2000
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Country
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Australia
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Phone
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+61 2 92898542
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Fax
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+61 2 92811982
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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