Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)
NCT ID: NCT00537082
Last Updated: 2011-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2007-09-30
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
TRIPLE
Study Groups
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FTY720 0.5 mg
FTY720
FTY720
Administered orally once daily for 6 months
FTY720 1.25 mg
FTY720
FTY720
Administered orally once daily for 6 months
Placebo
Placebo
Administered orally once daily for 6 months
Interventions
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FTY720
Administered orally once daily for 6 months
Placebo
Administered orally once daily for 6 months
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of multiple sclerosis
Exclusion Criteria
* Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
* Pregnant or nursing (lactating) women
18 Years
60 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Novartis
INDUSTRY
Principal Investigators
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Novartis Pharmaceuticals, Japan
Role: PRINCIPAL_INVESTIGATOR
+81 3 3797 8748
Locations
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Novartis Investigative site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Chiba, , Japan
Novartis Investigative Site
Ehime, , Japan
Novartis Investigative Site
Fukuoka, , Japan
Novartis Investigative Site
Gunma, , Japan
Novartis Investigative Site
Hyōgo, , Japan
Novartis Investigative Site
Ibaraki, , Japan
Novartis Investigative Site
Kanagawa, , Japan
Novartis Investigative Site
Kyoto, , Japan
Novartis Investigative Site
Kyoto, , Japan
Novartis Investigative Site
Niigata, , Japan
Novartis
Numakunai, , Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Osaka, , Japan
Novartis Investigative Site
Tochigi, , Japan
Novartis Investigative Site
Tokyo, , Japan
Novartis Investigative Site
Tokyo, , Japan
Novartis Investigative Site
Wakayama, , Japan
Countries
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References
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Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.
Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5.
Other Identifiers
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CFTY720D1201
Identifier Type: -
Identifier Source: org_study_id
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