Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT00662649
Last Updated: 2012-07-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
920 participants
INTERVENTIONAL
2008-02-29
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fingolimod 1.25 mg
Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg
Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo-fingolimod
Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Placebo-fingolimod 1.25 mg
Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Interventions
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Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or nursing women
20 Years
58 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chatswood, , Australia
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Fitzroy, , Australia
Austin Health, Department of Neurology
Heidelberg, , Australia
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North Gosford, , Australia
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Woodville, , Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Leuven, , Belgium
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Overpelt, , Belgium
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Sijsele - Damme, , Belgium
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Sint-Truiden, , Belgium
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Halifax, , Canada
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Kingston, , Canada
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London, , Canada
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Montreal, , Canada
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Nepean, , Canada
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Regina, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Brno, , Czechia
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Olomouc, , Czechia
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Ostrava-Poruba, , Czechia
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Pardubice, , Czechia
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Plzen - Lochotin, , Czechia
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Prague, , Czechia
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Rychnov nad Kněžnou, , Czechia
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Teplice, , Czechia
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Talinn, , Estonia
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Clermont-Ferrand, , France
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Dijon, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Berlin, , Germany
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Düsseldorf, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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München, , Germany
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Münster, , Germany
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Regensburg, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Miskolc, , Hungary
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Székesfehérvár, , Hungary
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Dublin, , Ireland
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Ashkelon, , Israel
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Haifa, , Israel
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Ramat Gan, , Israel
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Safed, , Israel
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Amsterdam, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Sittard, , Netherlands
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Tilburg, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Craiova, , Romania
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Lasi, , Romania
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Tg. Mures, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Martin, , Slovakia
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Žilina, , Slovakia
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Cape Town, , South Africa
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Rosebank, , South Africa
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Umhlanga, , South Africa
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Cerrahpasa/Istanbul, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Yenisehir/Izmir, , Turkey (Türkiye)
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Bristol, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
Countries
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Related Links
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Fingolimod clinical trials information website
Other Identifiers
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2007-004122-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720D2301E1
Identifier Type: -
Identifier Source: org_study_id