Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000142437
Ethics application status
Approved
Date submitted
1/02/2007
Date registered
23/02/2007
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy & Safety of Zonisamide in newly diagnosed partial epilepsy patients.
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
Secondary ID [1] 344 0
Eisai Ltd: E2090-E044-310
Universal Trial Number (UTN)
Trial acronym
MAZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly diagnosed partial epilepsy 1636 0
Condition category
Condition code
Neurological 1744 1744 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1582 0
Diagnosis / Prognosis
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
Control group
Active

Outcomes
Primary outcome [1] 2431 0
The proportion of subjects remaining seizure free for at least a 26 week period when treated with zonisamide or carbamazepine as compared to baseline.
Timepoint [1] 2431 0
Seizure diary will be measured at every visit from week 1 to week 56
Secondary outcome [1] 4199 0
Proportion of subjects seizure free for 52 weeks.
Timepoint [1] 4199 0
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.

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by site (using permuted blocks within site)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study a subject, an investigator and a sponsor will keep blinded
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2007
Actual
15/04/2007
Date of last participant enrolment
Anticipated
Actual
30/01/2011
Date of last data collection
Anticipated
Actual
30/01/2011
Sample size
Target
582
Accrual to date
Final
583
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 1893 0
Commercial sector/Industry
Name [1] 1893 0
Pharmaceutical Research Associate Ltd.
Country [1] 1893 0
Primary sponsor type
Commercial sector/Industry
Name
Eisai Ltd
Address
Country
United Kingdom
Secondary sponsor category [1] 1712 0
Commercial sector/Industry
Name [1] 1712 0
Pharmaceutical Research Associate Ltd.
Address [1] 1712 0
Country [1] 1712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3519 0
Flinders Medical Centre
Ethics committee address [1] 3519 0
Ethics committee country [1] 3519 0
Australia
Date submitted for ethics approval [1] 3519 0
Approval date [1] 3519 0
01/04/2007
Ethics approval number [1] 3519 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27516 0
Mrs This information is not available as the study was completed many years ago
Address 27516 0
This information is not available as the study was completed many years ago
Country 27516 0
Australia
Phone 27516 0
+61 2 92898542
Fax 27516 0
Email 27516 0
katariyanimisha@praintl.com
Contact person for public queries
Name 10771 0
Nimisha Katariya
Address 10771 0
PRA International
Level 17 Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country 10771 0
Australia
Phone 10771 0
+61 2 92898542
Fax 10771 0
+61 2 92811982
Email 10771 0
katariyanimisha@praintl.com
Contact person for scientific queries
Name 1699 0
Nimisha Katariya
Address 1699 0
PRA International
Level 17 Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country 1699 0
Australia
Phone 1699 0
+61 2 92898542
Fax 1699 0
+61 2 92811982
Email 1699 0
katariyanimisha@praintl.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.