Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000097347
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, multi centre study to assess the efficacy and safety of adjunctive zonisamide in myoclonic seizures associated with idiopathic generalised epilepsy.
Scientific title
placebo controlled adjunctive zonisamide in myoclonic seizures associated with idiopathic generalised epilepsy
Secondary ID [1] 522 0
E2090-E044-317
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 2791 0
Condition category
Condition code
Neurological 2927 2927 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 drugs. Patients will commence on a dose of 50mg. Further dose increases will occur at one week intervals until a dose of 300mg is reached by week 4. Patients will then maintain their dose for a further 12 weeks.
Intervention code [1] 2530 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] 3575 0
decrease of seizure frequency
Timepoint [1] 3575 0
a seizure diary will be used to collect information on frequency of Seizures. A diary will be collected from 8 weeks prior to the study until after 16 weeks of active therpay.
Secondary outcome [1] 5991 0
safety - blood samples will be taken and assessed for safty Laboratory values.
Timepoint [1] 5991 0
At screening and final visit (after 16 weeks of active therapy)

Eligibility
Key inclusion criteria
myoclonic seizures
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
other type of seizures

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)
Sunjects 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 tusing 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
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 566 0
3050
Recruitment postcode(s) [2] 756 0
3084
Recruitment postcode(s) [3] 757 0
2031
Recruitment postcode(s) [4] 758 0
2067
Recruitment postcode(s) [5] 759 0
3065
Recruitment outside Australia
Country [1] 681 0
Croatia
State/province [1] 681 0
Country [2] 682 0
Czech Republic
State/province [2] 682 0
Country [3] 683 0
Estonia
State/province [3] 683 0
Country [4] 684 0
Germany
State/province [4] 684 0
Country [5] 685 0
Hungary
State/province [5] 685 0
Country [6] 686 0
Lithuania
State/province [6] 686 0
Country [7] 687 0
Poland
State/province [7] 687 0
Country [8] 688 0
Serbia and Montenegro
State/province [8] 688 0
Country [9] 689 0
Russian Federation
State/province [9] 689 0
Country [10] 690 0
Ukraine
State/province [10] 690 0
Country [11] 691 0
Romania
State/province [11] 691 0
Country [12] 692 0
Spain
State/province [12] 692 0

Funding & Sponsors
Funding source category [1] 3052 0
Commercial sector/Industry
Name [1] 3052 0
Eisai Ltd
Country [1] 3052 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisai Ltd.
Address
3 Shortlands
London
W6 8EE
UK
Country
United Kingdom
Secondary sponsor category [1] 2734 0
Other
Name [1] 2734 0
Parexel Int.
Address [1] 2734 0
3 Thomas Holt Drive
North Ryde, NSW
2113
Country [1] 2734 0
Australia
Secondary sponsor category [2] 2750 0
Other
Name [2] 2750 0
Parexel International
Address [2] 2750 0
101-105 Oxford Rd.
The Quays
Uxbrudge, Middlesex,
UB8 1LZ
Country [2] 2750 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4986 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 4986 0
Ward 6 East, Research Directorate
Gratten St
Parkville
VIC 3050
Ethics committee country [1] 4986 0
Australia
Date submitted for ethics approval [1] 4986 0
21/11/2007
Approval date [1] 4986 0
20/02/2008
Ethics approval number [1] 4986 0
2007.288
Ethics committee name [2] 4987 0
Northern Sydney Central Coast Human Research Ethics Commitee
Ethics committee address [2] 4987 0
Research Office, RNSH
Level 4
Vindin House,
Pacific Highway, St Leonards
NSW 2065
Ethics committee country [2] 4987 0
Australia
Date submitted for ethics approval [2] 4987 0
10/01/2008
Approval date [2] 4987 0
09/07/2008
Ethics approval number [2] 4987 0
08/HARBA/3/4
Ethics committee name [3] 4988 0
Austin Health Human Research Ethics Commitee
Ethics committee address [3] 4988 0
Research Ethics Unit (REU)
Level 8, Room 8322
Harold Stokes Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria
3084
Ethics committee country [3] 4988 0
Australia
Date submitted for ethics approval [3] 4988 0
16/01/2008
Approval date [3] 4988 0
04/06/2008
Ethics approval number [3] 4988 0
H2008/03172
Ethics committee name [4] 5003 0
St Vincents Hospital (melbourne) Human Research Ethics Committee
Ethics committee address [4] 5003 0
Level 5, Aikenhead Building
27 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [4] 5003 0
Australia
Date submitted for ethics approval [4] 5003 0
31/01/2008
Approval date [4] 5003 0
Ethics approval number [4] 5003 0
015/08

Summary
Brief summary
This study is designed to compare how safe and effective zonisamide is compared to placebo in people with myoclonic seizures associated with idiopathic generalised epilepsy who are already being treated with one or two other anti-epileptic drugs. Zonisamide is an investigational drug.
RESEARCH OBJECTIVES
To assess the efficacy of adjunctive zonisamide in idiopathic generalised epilepsy (IGE) in reducing the frequency of myoclonic seizures in subjects with continuing seizures despite treatment with 1 or 2 other anti epileptic drugs (AEDs). To assess the safety and tolerability of zonisamide and explore further efficacy in other seizure types.

STUDY DESIGN
This is a double blind, randomised, placebo controlled study comparing zonisamide and placebo in 110 subjects (1:1ratio). The study consists fo Baseline, Titration and Maintenance periods.

Baseline Period once the Screening Visit has been performed, a seizure diary will be maintained to document the baseline seizure frequency in the eight weeks before the Randomisation Visit. Titration Period zonisamide/placebo dose will commence at at 50 mg. Further dose increases will occur at one week intervals until at dose of 300 mg is reached by Week 4. If adverse events (AEs) occur, one titration step will be omitted during Weeks 0 3, in which case the dose reached at Week 4 will be 250 mg. Subjects who require further down titration during this period will be withdrawn.

Maintenance Period subjects will be treated with their Week 4 dose. In the event of seizures occurring in the first two weeks of the Maintenance Period, the dose will be increased to 400 mg (or 350 mg, if the subject omitted one dose in the Titration Period and the AE that led to this dose increase omission has subsided). The dose can be reduced to 200 mg in the case of dose-limiting AEs. Subjects who require further down titration or dose increases will be withdrawn (with the exception of those who had temporary dose decreases for not more that 4 days when necessitated by intercurrent illness). During the remainder of the Maintenance Period, the dose of study medication must remain unchanged.

During the entire study the patient will keep a seizure diary to ascertain seizure frequency and type. Adverse events (AEs) will be reviewed at every visit, also physical and neurological exams and orthostatic vitals will be collected at every visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28197 0
Address 28197 0
Country 28197 0
Phone 28197 0
Fax 28197 0
Email 28197 0
Contact person for public queries
Name 11354 0
Sophie Nzongani-Morin
Address 11354 0
PAREXEL International
190 Rue Championnet
PARIS, 75018
Country 11354 0
France
Phone 11354 0
+33 1 44 90-32 31
Fax 11354 0
Email 11354 0
[email protected]
Contact person for scientific queries
Name 2282 0
Janos Antal
Address 2282 0
Hermina utca 17, Budapest, 1146 Hungary
Country 2282 0
Hungary
Phone 2282 0
36 1 461 7600
Fax 2282 0
Email 2282 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

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