Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000124437
Ethics application status
Approved
Date submitted
29/11/2006
Date registered
12/02/2007
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Efficacy of BG00012 in Relapsing Remitting Multiple Sclerosis
Scientific title
A Randomized, Multicentre, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Safety and Efficacy of BG00012 in Subjects with Relapsing Remitting Multiple Sclerosis
Secondary ID [1] 340 0
Biogen Idec: 109MS301
Secondary ID [2] 341 0
European Union Clinical Trials Database (EUDRACT): 2006-003696-12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis (Relapsing Remitting) 1616 0
Condition category
Condition code
Neurological 1724 1724 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BG00012; Group 1 will receive 480 mg daily orally via 2 capsules 3 times daily. Each capsule will contain either 120 mg BG00012 or placebo (lactose monohydrate). Group 2 will receive 720 mg daily orally via 2 capsules 3 times daily. Each capsule will contain 120 mg BG00012.
Treatment will be for 2 years.
Intervention code [1] 1479 0
Treatment: Drugs
Comparator / control treatment
Group 3 will receive placebo capsules (containing lactose monohydrate) orally via 2 capsules 3 times daily.
Treatment will be for 2 years.
Control group
Placebo

Outcomes
Primary outcome [1] 2395 0
Proportion of relapsing subjects compared between BG00012 treatment groups and placebo group
Timepoint [1] 2395 0
At 2 years
Secondary outcome [1] 4158 0
Annual relapse rate, rate of disability progression as measured by MSFC; (In a subset of patients: new or enlarging T2 hyperintense lesions, Gd-enhancing lesions and T1 hypointense lesions on brain MRI).
Timepoint [1] 4158 0
At 1 year
Secondary outcome [2] 4159 0
Disability Progression as measured by EDSS and MSFC; (In a subset of patients: volume of T2 hyperintense and T1 hypointense lesions on brain MRI).
Timepoint [2] 4159 0
At 2 years

Eligibility
Key inclusion criteria
Confirmed diagnosis of relapsing remitting multiple sclerosis according to McDonald criteria #1-4At least 1 relapse within 12 months prior to randomization with cranial MRI demonstrating MS consistent lesions, OR evidence of Gadolinium enhancing brain lesions on MRI within 6 weeks prior to randomisationBaseline Expanded Disability Status Score (EDSS) between 0.0 and 5.0.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary progressive, secondary progressive or progressive relapsing Multiple SclerosisAn MS relapse within 50 days of randomisation OR a patient who has not stabilised from a previous relapse prior to randomisationInability to perform Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, PASAT 3, or Visual Function testHistory of MalignancyHistory of severe allergic or anaphylactic reactions/known drug hypersensitivityHistory of HIVHistory of Drug or Alcohol abuse in last 2 yearsPositive for Hep C antibody and/or Hep B surface antigenAbnormal laboratory results indicative of major disease which would preclude clinical trial participationAny previous treatment with FUMADERM or BG00012/FAG-201History of other disallowed medication use outside of the time-frames specified in the protocolWomen of child-bearing potential not using adequate contraceptionEnrolment in other clinical trials within 6 months prior to randomisation.

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)
Central randomisation via phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All subjects, physicians, data analysts and assessors will be blinded to subject's treatment.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1011
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1873 0
Commercial sector/Industry
Name [1] 1873 0
Biogen Idec
Country [1] 1873 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Biogen Idec
Address
Thames House, 5 Roxborough Way, Maidenhead, Berks SL6 3UD, United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 1688 0
None
Name [1] 1688 0
Nil
Address [1] 1688 0
Country [1] 1688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3490 0
Royal Prince Alfred Hospital
Ethics committee address [1] 3490 0
Camperdown, NSW
Ethics committee country [1] 3490 0
Australia
Date submitted for ethics approval [1] 3490 0
Approval date [1] 3490 0
Ethics approval number [1] 3490 0
Ethics committee name [2] 3491 0
St Vincent's Hospital
Ethics committee address [2] 3491 0
Melbourne, VIC
Ethics committee country [2] 3491 0
Australia
Date submitted for ethics approval [2] 3491 0
Approval date [2] 3491 0
Ethics approval number [2] 3491 0
Ethics committee name [3] 3492 0
John Hunter Hospital
Ethics committee address [3] 3492 0
Newcastle, NSW
Ethics committee country [3] 3492 0
Australia
Date submitted for ethics approval [3] 3492 0
Approval date [3] 3492 0
Ethics approval number [3] 3492 0

Summary
Brief summary
The purpose of the study is to determine whether BG00012 is effective in reducing the proportion of patients experiencing a clinical relapse at 2 years compared to placebo in patients with relapsing remitting multiple sclerosis. Two different doses of BG00012 will be compared to placebo.
Patients will be randomised to one of 3 groups in a 1:1:1 ratio:
Group 1 will receive 480 mg daily orally via 2 capsules 3 times daily. Each capsule will contain either 120 mg BG00012 or placebo.
Group 2 will receive 720 mg daily orally via 2 capsules 3 times daily. Each capsule will contain 120 mg BG00012.
Group 3 will receive placebo orally via 2 capsules 3 times daily.
Patients will have the option of switching to open label Avonex (interferon beta-1a) if they experience relapse after 24 weeks and have completed 48 weeks of double blind treatment, OR they experience disability progression sustained for 12 weeks at any time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27413 0
Address 27413 0
Country 27413 0
Phone 27413 0
Fax 27413 0
Email 27413 0
Contact person for public queries
Name 10668 0
Prof John Pollard
Address 10668 0
Department of Medicine, Blackburn Building, University of Sydney, NSW 2006
Country 10668 0
Australia
Phone 10668 0
61 2 9351 3385
Fax 10668 0
61 9 9351 4018
Email 10668 0
[email protected]
Contact person for scientific queries
Name 1596 0
Karen Smith
Address 1596 0
C/O Biogen Idec Australia Pty Ltd
PO Box 380
North Ryde BC
NSW 1670
Country 1596 0
Australia
Phone 1596 0
02 8875 3915
Fax 1596 0
02 9889 1162
Email 1596 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.