Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
NCT ID: NCT01333501
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
151 participants
INTERVENTIONAL
2011-05-31
2015-09-30
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
NONE
Study Groups
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Fingolimod
0.5 mg in capsules for oral administration once daily
Fingolimod
0.5 mg in capsules for oral administration once daily
Interferon beta 1b
250 μg injected s.c. every other day
Interferon beta 1b
250 μg injected s.c. every other day
Interventions
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Fingolimod
0.5 mg in capsules for oral administration once daily
Interferon beta 1b
250 μg injected s.c. every other day
Eligibility Criteria
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Inclusion Criteria
* Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months.
* Patients with cognitive impairment at screening, defined as at least one test of the Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the normative data.
Exclusion Criteria
* Patients with hyperactive forms of the MS disease according to the judgment of the investigator.
* Patients with an EDSS score higher than 5.
* Patients with a prior or current diagnosis of Major Depression according to DSM-IV.
* Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome.
18 Years
50 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Alzenau in Unterfranken, , Germany
Novartis Investigative Site
Bamberg, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Montichiari, BS, Italy
Novartis Investigative Site
Chieti, CH, Italy
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Pozzilli, IS, Italy
Novartis Investigative Site
Messina, ME, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Cefalù, PA, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Gallarate, VA, Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Napoli, , Italy
Countries
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Other Identifiers
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2010-023023-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720DIT01
Identifier Type: -
Identifier Source: org_study_id
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