Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000096358
Ethics application status
Approved
Date submitted
13/02/2008
Date registered
20/02/2008
Date last updated
21/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind, randomised, placebo-controlled, mulitcentre study to assess the efficacy and safety of adjunctive zonisamide in primary generalised tonic clonic seizures.
Scientific title
Efficacy and safety of adjuntice zonisamide in primary generalised tonic clonic seizures
Secondary ID [1] 521 0
E2090- E044-315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
epilepsy 2564 0
Condition category
Condition code
Neurological 2666 2666 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
adjunctive therapy - Zonisamide. Patients will take study drug (either Zonisamide or placebo) alongside their usual Antiepileptic drug's. Patient's will commence on a dose of 1mg/kg (subjects<12 years or 50mg (subjects >12 years). Further dose increases will occur at one week intervals until a dose of 5mg/kg or 300mg is reached by week 4. Patients will then maintain their dose for futher 12 weeks.
Intervention code [1] 2296 0
Treatment: Drugs
Comparator / control treatment
Placebo will be the comparator to Zonisamide. Placebo will be dispensed in the same way as Zonisamide.
Control group
Placebo

Outcomes
Primary outcome [1] 3574 0
decrease of seizure frequency
Timepoint [1] 3574 0
after 16 weeks of active therapy
Secondary outcome [1] 5990 0
safety - blood samples will be taken and assessed for safety laboratory values.
Timepoint [1] 5990 0
At screening and final visit (after 16 weeks of active therapy)

Eligibility
Key inclusion criteria
primary generalized tonic clonic seizures
Minimum age
6 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
any other type of epilepsy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled and allocated to a treatment using a central randomisation system by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised using a central randomisation system which will determine the sequence of patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
20/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 565 0
3050,
Recruitment postcode(s) [2] 760 0
3084
Recruitment postcode(s) [3] 761 0
2031
Recruitment postcode(s) [4] 762 0
2067
Recruitment postcode(s) [5] 763 0
3065
Recruitment outside Australia
Country [1] 667 0
Germany
State/province [1] 667 0
Country [2] 668 0
Finland
State/province [2] 668 0
Country [3] 669 0
Lithuania
State/province [3] 669 0
Country [4] 670 0
Czech Republic
State/province [4] 670 0
Country [5] 671 0
Hungary
State/province [5] 671 0
Country [6] 672 0
Estonia
State/province [6] 672 0
Country [7] 673 0
Russian Federation
State/province [7] 673 0
Country [8] 674 0
Ukraine
State/province [8] 674 0
Country [9] 675 0
Serbia and Montenegro
State/province [9] 675 0
Country [10] 676 0
Romania
State/province [10] 676 0
Country [11] 677 0
Croatia
State/province [11] 677 0
Country [12] 678 0
Croatia
State/province [12] 678 0
Country [13] 679 0
Poland
State/province [13] 679 0
Country [14] 680 0
Spain
State/province [14] 680 0

Funding & Sponsors
Funding source category [1] 3025 0
Commercial sector/Industry
Name [1] 3025 0
Eisai Global Clinical Development, Eisia Ltd.
Country [1] 3025 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisia G.C.D., Eisai Ltd.
Address
3 Shortlands, London, W6 8EE, UK
Country
United Kingdom
Secondary sponsor category [1] 2731 0
Other Collaborative groups
Name [1] 2731 0
Parexel International Limited
Address [1] 2731 0
The Quays
101-105 Oxford Road, Uxbridge, Middlesex, UB8 1LZ
Country [1] 2731 0
United Kingdom
Secondary sponsor category [2] 2732 0
Other Collaborative groups
Name [2] 2732 0
Parexel International Limited
Address [2] 2732 0
3 Thomas Holt Drive
North Ryde
NSW 2113
Country [2] 2732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4981 0
Royal Melbourne Human Research Ethics Committee
Ethics committee address [1] 4981 0
Ethics committee country [1] 4981 0
Australia
Date submitted for ethics approval [1] 4981 0
21/11/2007
Approval date [1] 4981 0
20/02/2008
Ethics approval number [1] 4981 0
2007-287
Ethics committee name [2] 4982 0
Northern Sydney Central Coast Human Research Ethics Committee
Ethics committee address [2] 4982 0
Ethics committee country [2] 4982 0
Australia
Date submitted for ethics approval [2] 4982 0
10/01/2008
Approval date [2] 4982 0
Ethics approval number [2] 4982 0
08/HARBR/7/8
Ethics committee name [3] 4983 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 4983 0
Ethics committee country [3] 4983 0
Australia
Date submitted for ethics approval [3] 4983 0
16/01/2008
Approval date [3] 4983 0
04/06/2008
Ethics approval number [3] 4983 0
H2008/03171
Ethics committee name [4] 5004 0
St Vincents Hospital (melbourne) Human Research Ethics Committee
Ethics committee address [4] 5004 0
Ethics committee country [4] 5004 0
Australia
Date submitted for ethics approval [4] 5004 0
31/01/2008
Approval date [4] 5004 0
Ethics approval number [4] 5004 0
014/08

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

Contacts
Principal investigator
Name 28196 0
Address 28196 0
Country 28196 0
Phone 28196 0
Fax 28196 0
Email 28196 0
Contact person for public queries
Name 11353 0
Sophie Nzongani-Morin
Address 11353 0
190 Rue Championnet
PARIS, 75018
Country 11353 0
France
Phone 11353 0
+33 1 44 90-32 31
Fax 11353 0
Email 11353 0
[email protected]
Contact person for scientific queries
Name 2281 0
Janos Antal M.D.
Address 2281 0
Hermina utca 17.
Budapest, H-1146
Country 2281 0
Hungary
Phone 2281 0
36 1 461-7600
Fax 2281 0
Email 2281 0
[email protected]

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.