ID
15725
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: Visit 3 (Week 12)
Keywords
Versions (1)
- 6/9/16 6/9/16 -
Uploaded on
June 9, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Visit 3 (Week 12): EDSS evaluation BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 3 (Week 12): EDSS evaluation BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
EDSS Evaluation
Description
Functional System Scores
Description
Visual System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Description
Brainstem System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Description
Pyramidal System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Description
Cerebellar System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Description
Sensory System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Description
Bowel or Bladder System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Description
Cerebral System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Description
Additional and Results
Description
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Data type
text
Alias
- UMLS CUI [1]
- C0429886
Description
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Data type
integer
Alias
- UMLS CUI [1]
- C0429886
Description
EDSS score
Data type
float
Alias
- UMLS CUI [1]
- C0451246
Description
Name of Neurologist
Data type
text
Alias
- UMLS CUI [1,1]
- C0237426
- UMLS CUI [1,2]
- C0027365
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Visit 3 (Week 12): EDSS evaluation BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
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