Multiple sclerosis
Conditions
Brief summary
EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once., SAFETY: - Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. - Proportion of patients with any Grade 3 -4 adverse events related to study product.
Interventions
DRUGTolDec
Sponsors
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once., SAFETY: - Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. - Proportion of patients with any Grade 3 -4 adverse events related to study product. | — |
Countries
Spain
Outcome results
None listed