Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT00333138
Last Updated: 2017-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
281 participants
INTERVENTIONAL
2003-05-31
2011-04-30
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
DOUBLE
Study Groups
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Fingolimod (FTY720) 1.25 mg/day
Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
FTY720
FTY720 capsule was taken orally once a day
Placebo/Fingolimod (FTY720)
Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
Placebo
Placebo 1.25 mg capsule was given once daily
Fingolimod (FTY720) 5.0 mg/day
Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
FTY720
FTY720 capsule was taken orally once a day
Interventions
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FTY720
FTY720 capsule was taken orally once a day
Placebo
Placebo 1.25 mg capsule was given once daily
Eligibility Criteria
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Inclusion Criteria
* Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
* Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
Extension Study
* A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
* Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
* Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
Exclusion Criteria
* Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
* Pregnant or nursing women
Extension Study
* Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
* Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
18 Years
60 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 Investigational site
Montreal, , Canada
Novartis Investigational site
Ottawa, , Canada
Novartis Investigational site
Toronto, , Canada
Novartis Investigational site
Vancouver, , Canada
Novartis Investigational site
Copenhagen, , Denmark
Novartis Investigational site
Helsinki, , Finland
Novartis Investigational site
Turku, , Finland
Novartis Investigational site
Lille, , France
Novartis Investigational site
Marseille, , France
Novartis Investigational site
Schwendi, , Germany
Novartis Investigational site
Würzburg, , Germany
Novartis Investigational site
Gallarate, , Italy
Novartis Investigational site
Genova, , Italy
Novartis Investigational site
Milan, , Italy
Novartis Investigational site
Roma, , Italy
Novartis Investigational site
Warsaw, , Poland
Novartis Investigational site
Coimbra, , Portugal
Novartis Investigational site
Lisbon, , Portugal
Novartis Investigational site
Barcelona, , Spain
Novartis Investigational site
Madrid, , Spain
Novartis Investigational site
Málaga, , Spain
Novartis Investigational site
Seville, , Spain
Novartis Investigational site
Valencia, , Spain
Novartis Investigational site
Basel, , Switzerland
Novartis Investigational site
Zurich, , Switzerland
Novartis Investigational site
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.
Other Identifiers
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CFTY720D2201E1
Identifier Type: OTHER
Identifier Source: secondary_id
CFTY720D2201
Identifier Type: -
Identifier Source: org_study_id
NCT00235430
Identifier Type: -
Identifier Source: nct_alias
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