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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00420212




Registration number
NCT00420212
Ethics application status
Date submitted
8/01/2007
Date registered
11/01/2007
Date last updated
26/01/2015

Titles & IDs
Public title
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Scientific title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 0 0
109MS301
Universal Trial Number (UTN)
Trial acronym
DEFINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: Placebo - Participants received two placebo capsules orally three times daily (TID)

Experimental: BG00012 240 mg Twice Daily (BID) - Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)

Experimental: BG00012 240 mg 3 Times Daily (TID) - Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects Relapsed
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Number of New or Newly Enlarging T2 Hyperintense Lesions
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Number of Gadolinium-enhancing T1-weighted Lesions
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Number of Subjects With Gadolinium (Gd)-Enhancing Lesions
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Annualized Relapse Rate
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
Key

* Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
* Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
* Must have a baseline EDSS between 0.0 and 5.0, inclusive.
* Must have relapsing-remitting disease course.

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
* Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
* Pregnant or nursing women.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
1234
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Chatswood
Recruitment hospital [3] 0 0
Research Site - Fitzroy
Recruitment hospital [4] 0 0
Research Site - Geelong
Recruitment hospital [5] 0 0
Research Site - Heidelberg
Recruitment hospital [6] 0 0
Research Site - Kogarah
Recruitment hospital [7] 0 0
Research Site - Liverpool
Recruitment hospital [8] 0 0
Research Site - Melbourne
Recruitment hospital [9] 0 0
Research Site - Newcastle
Recruitment postcode(s) [1] 0 0
- Camperdown
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- Chatswood
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- Fitzroy
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- Geelong
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- Heidelberg
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- Kogarah
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- Liverpool
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- Melbourne
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- Newcastle
Recruitment outside Australia
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North Carolina
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Washington
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Graz
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Linz
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00420212