ID
15682
Description
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Baseline Visit (Day 1)
Keywords
Versions (1)
- 6/8/16 6/8/16 -
Uploaded on
June 8, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
Inclusion/Exclusion
Description
Protocol Version
Data type
text
Alias
- UMLS CUI [1]
- C2985700
Description
informed consent date
Data type
text
Alias
- UMLS CUI [1]
- C2985782
Description
If no, record the unmet criterion numbers as indicated in the protocol.
Data type
boolean
Alias
- UMLS CUI [1]
- C1516637
Description
Inclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Inclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Inclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Similar models
Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0600091 (UMLS CUI [1,2])