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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - BG00012
Treatment: Drugs - Placebo

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)


Treatment: Drugs: BG00012


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
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
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- Camperdown
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- Newcastle
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a
certain time period. To determine if, over time, BG00012 treatment can decrease the number of
certain types of brain lesions commonly seen in MS patients and slow down the time it takes
for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is
tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used
to assess MS.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00420212
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