BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
NCT ID: NCT02430532
Last Updated: 2017-04-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
58 participants
INTERVENTIONAL
2015-05-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dimethyl fumarate
BG00012 120 mg (1 BG00012 120 mg capsule + 1 matching placebo capsule) orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID thereafter.
dimethyl fumarate
capsule
Placebo
matched placebo capsule
Placebo
BG00012 120 mg capsule orally once a day supplemented with matching placebo capsules for the first 4 weeks of treatment, as an additional blinding measure. Matched placebo capsules only thereafter.
dimethyl fumarate
capsule
Placebo
matched placebo capsule
Interventions
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dimethyl fumarate
capsule
Placebo
matched placebo capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization.
* Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.
* Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.
Exclusion Criteria
* Had a recent clinical relapse (within 3 months) prior to randomization.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
18 Years
58 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Long Beach, California, United States
Research Site
San Francisco, California, United States
Research Site
Tampa, Florida, United States
Research Site
Vero Beach, Florida, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Willow Grove, Pennsylvania, United States
Research Site
Round Rock, Texas, United States
Research Site
Brussels, , Belgium
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Sittard-Geleen, , Netherlands
Research Site
Gdansk, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Plewiska, , Poland
Research Site
Poznan, , Poland
Research Site
Banská Bystrica, , Slovakia
Countries
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Other Identifiers
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2014-003021-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
109MS308
Identifier Type: -
Identifier Source: org_study_id
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