ANZCTR - Registration

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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]

E2090-E044-317

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Epilepsy

Condition category

Condition code

Neurological

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]

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]

decrease of seizure frequency

Timepoint [1]

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]

safety - blood samples will be taken and assessed for safty Laboratory values.

Timepoint [1]

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?

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]

3050

Recruitment postcode(s) [2]

3084

Recruitment postcode(s) [3]

2031

Recruitment postcode(s) [4]

2067

Recruitment postcode(s) [5]

3065

Recruitment outside Australia

Country [1]

Croatia

State/province [1]

Country [2]

Czech Republic

State/province [2]

Country [3]

Estonia

State/province [3]

Country [4]

Germany

State/province [4]

Country [5]

Hungary

State/province [5]

Country [6]

Lithuania

State/province [6]

Country [7]

Poland

State/province [7]

Country [8]

Serbia and Montenegro

State/province [8]

Country [9]

Russian Federation

State/province [9]

Country [10]

Ukraine

State/province [10]

Country [11]

Romania

State/province [11]

Country [12]

Spain

State/province [12]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Eisai Ltd

Address [1]

3 Shortlands
London
W6 8EE

Country [1]

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]

Other

Name [1]

Parexel Int.

Address [1]

3 Thomas Holt Drive
North Ryde, NSW
2113

Country [1]

Australia

Secondary sponsor category [2]

Other

Name [2]

Parexel International

Address [2]

101-105 Oxford Rd.
The Quays
Uxbrudge, Middlesex,
UB8 1LZ

Country [2]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Ward 6 East, Research Directorate
Gratten St
Parkville
VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2007

Approval date [1]

20/02/2008

Ethics approval number [1]

2007.288

Ethics committee name [2]

Northern Sydney Central Coast Human Research Ethics Commitee

Ethics committee address [2]

Research Office, RNSH
Level 4
Vindin House,
Pacific Highway, St Leonards
NSW 2065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

10/01/2008

Approval date [2]

09/07/2008

Ethics approval number [2]

08/HARBA/3/4

Ethics committee name [3]

Austin Health Human Research Ethics Commitee

Ethics committee address [3]

Research Ethics Unit (REU)
Level 8, Room 8322
Harold Stokes Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria
3084

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

16/01/2008

Approval date [3]

04/06/2008

Ethics approval number [3]

H2008/03172

Ethics committee name [4]

St Vincents Hospital (melbourne) Human Research Ethics Committee

Ethics committee address [4]

Level 5, Aikenhead Building
27 Victoria Parade
Fitzroy 
VIC 3065

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

31/01/2008

Approval date [4]

Ethics approval number [4]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Sophie Nzongani-Morin

Address

PAREXEL International
190 Rue Championnet
PARIS, 75018

Country

France

Phone

+33 1 44 90-32 31

Fax

Sophie.Nzongani-Morin@parexel.com

Contact person for scientific queries

Name

Janos Antal

Address

Hermina utca 17, Budapest, 1146 Hungary

Country

Hungary

Phone

36 1 461 7600

Fax

janos.antal@parexel.com

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.

Trial Review

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