ANZCTR - Registration

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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]

E2090- E044-315

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 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]

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]

after 16 weeks of active therapy

Secondary outcome [1]

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

Timepoint [1]

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?

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]

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]

Germany

State/province [1]

Country [2]

Finland

State/province [2]

Country [3]

Lithuania

State/province [3]

Country [4]

Czech Republic

State/province [4]

Country [5]

Hungary

State/province [5]

Country [6]

Estonia

State/province [6]

Country [7]

Russian Federation

State/province [7]

Country [8]

Ukraine

State/province [8]

Country [9]

Serbia and Montenegro

State/province [9]

Country [10]

Romania

State/province [10]

Country [11]

Croatia

State/province [11]

Country [12]

Croatia

State/province [12]

Country [13]

Poland

State/province [13]

Country [14]

Spain

State/province [14]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Eisai Global Clinical Development, Eisia Ltd.

Address [1]

3 Shortlands, London. W6 8EE, UK

Country [1]

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]

Other Collaborative groups

Name [1]

Parexel International Limited

Address [1]

The Quays
101-105 Oxford Road, Uxbridge, Middlesex, UB8 1LZ

Country [1]

United Kingdom

Secondary sponsor category [2]

Other Collaborative groups

Name [2]

Parexel International Limited

Address [2]

3 Thomas Holt Drive
North Ryde
NSW 2113

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Melbourne 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]

2007-287

Ethics committee name [2]

Northern Sydney Central Coast Human Research Ethics Committee

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]

Ethics approval number [2]

08/HARBR/7/8

Ethics committee name [3]

Austin Health Human Research Ethics Committee

Ethics committee address [3]

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]

H2008/03171

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]

014/08

Summary

Brief summary

This study is designed to compare how safe and effective zonisamide is compared to placebo in people with primary generalised tonic clonic seizures who are already being treated with one or two other anti-epileptic drugs. Zonisamide is an investigational drug.
Primary Research Objective:  To assess the efficacy of adjunctive zonisamide in IGE in reducing the frequency of tonic-clonic seizures in subjects with continuing continuing primary generalised tonic-clonic seizures
Secondary Research Objective:  To assess the safety and tolerability of adjunctive zonisamide.
Exploratory Research Objective: To further explore the efficacy of zonisamide on other seizure types expected to occur in a significant proportion of subjects (myoclonic seizures, absence seizures).
This is a double-blind, randomised, placebo-controlled study comparing zonisamide and placebo in 154 subjects (1:1 ratio). The study consists of 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 1 mg/kg in subjects <12 years of age or at 50 mg for subjects 12 years of age. Further dose increases will occur at one week intervals until at dose of 5 mg/kg or 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 4 mg/kg or 250 mg. Subject's who require further down titration will be withdrawn from the study.

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 6 mg/kg or 400 mg (or 5 mg/kg 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 will be reduced to 4 mg/kg or 200 mg in 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, orthostatic vitals, 12 lead ECGs and clinical labs 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

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 M.D.

Address

Hermina utca 17.
Budapest, H-1146

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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