Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT00289978
Last Updated: 2012-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1272 participants
INTERVENTIONAL
2006-01-31
2009-07-31
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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Fingolimod 1.25 mg
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo
Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.
Interventions
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Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.
Eligibility Criteria
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Inclusion Criteria
* Patients with a relapsing-remitting disease course
* Patients with EDSS score of 0-5.5
Exclusion Criteria
* Pregnant or nursing women
18 Years
55 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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The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
North Gosford Private Hospital
Burrabil Avenue, Suite 17, Gosford, , Australia
Strategic Health Evaluators
Chatswood, , Australia
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
Fitzroy, , Australia
Austin Health, Department of Neurology
Heidelberg, , Australia
Algemeen Ziekenhuis St. Jan, Department of Neurology
Ruddershove, Brugge, Belgium
Erasme Hospital
Route de Lennik 808, Brussels Capital, Belgium
CHU Charleroi, Hôpital Civil
Boulevard Paul Janson 92, Charleroi, Belgium
University Hospital Gasthuisberg
Department Neurology, Herestraat 49, Leuven, Belgium
AZ Alma
Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, Belgium
Regionaal Ziekenhuis
St.Trudo, Diestersteenweg 100,, St.Truiden, Belgium
MS Klinik
Boemerangstraat 2, Overpelt, , Belgium
National Multiple Sclerose Centrum v.z.w
Vanheylenstraat 16, Melsbroek, , Belgium
University of British Columbia
Me498 2211 Wesbrook Mall, Vancouver, British Columbia, Canada
DMSRU - Capital Health
Halifax, Nova Scotia, Canada
Kingston General Hospital, MS Clinic
Connell 7, 76 Stuart Street, Kingston, Ontario, Canada
Nepean Medical Center
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Clinical Trials Office,
Trillium Health Center, 00 Queesway West, Mississauga, Ontario, Canada
Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
Montreal, Quebec, Canada
University of Saskatchewan
Regina, Saskatchewan, Canada
Military Hospital of Brno
Department of Neurology, Zabrdovicka 3, Brno, Czechia
Faculty Hospital St. Anne
First Department of Neurology, Pekarska 53, Brno, Czechia
Faculty Hospital
Department of Neurology, I.P. Paulova 6, Olomouc, Czechia
Hospital of Pardubice
Department of Neurology, Kyjevska 44, Pardubice, Czechia
Faculty Hospital
Department of Neurology, Alej Svobody 80, Plzeň, Czechia
Neurologicka klinika, Fakultni nemocnice
Kralovske Vinohrady, Srobarova 50, Prague, Czechia
Faculty Hospital Motol, MS Center
Department of Neurology, V Uvalu 84, Prague 5, Czechia
Vseobecna fakultni nemocnice
MS Centrum, Neurologicka Klinika, Karlovo Namesti 32, Praha 2, Czechia
MS Centrum
Neurology Department of Hospital Teplice, Duchcovska 53, Teplice, Czechia
Centrum neurologicke pece
Jiraskova 1389, Rychnov Nad Kneznou, , Czechia
Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
Ostrava, , Czechia
Helsinki Headache Center Postitalon Lääkäriasema
Mannnerheiminaukio 1 B 2 Floor, Helsinki, Finland
Finnish Special Neurology Center Ltd.
Brahenkatu 11 D,, Turku, Finland
Suomen Terveystalo/ Päänsärkykeskus, Tampere
Hämeenkatu 18, 6th Fl., Tampere, , Finland
Turku University Hospital, Neurology Department 799
Kiinanmyllynkatu 11- 14, Turku, , Finland
Hyvinkään sairaala
Neurologian Poliklinikka, Sairaalankatu 1, Hyvinkää, , Finland
CHU La Timone
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5, , France
Investigational Site
Berlin, , Germany
Investigational Site
Berlin, , Germany
Investigational Site
Düsseldorf, , Germany
Investigational Site
Giessen, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Leipzig, , Germany
Investigational Site
Magdeburg, , Germany
Investigational Site
München, , Germany
Investigational Site
München, , Germany
Investigational Site
Münster, , Germany
Investigational Site
Regensburg, , Germany
Investigational Site
Seesen/Harz, , Germany
Investigational Site
Stuttgart, , Germany
Investigational Site
Tübingen, , Germany
Investigational Site
Würzburg, , Germany
Athens Naval Hospital, Neurology Department
Athens, , Greece
Neurology Department Athens General Hospital, G. Gennimatas
Mesogeion 154 Ave., Athens, , Greece
1st IKA Papadimitriou Neurology Dept
Terma Zaimi, Melissia-Athens, , Greece
University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
Thessaloniki, , Greece
Barzilai Medical Center
Ashkelon, , Israel
Carmel Medical Center
Haifa, , Israel
Sieff Medical Center
Safed, , Israel
Sheba - Medical Center
Tel Hashomer, Ramat-Gan,, , Israel
Kaunas University Hospital Department of Neurology
Eiveniu 2, Kaunas, , Lithuania
Academisch Ziekenhuis VU
De Boelelaan 1118, Amsterdam, Netherlands
St. Antonius Ziekenhuis
Postbus 2500, Nieuwegein, Netherlands
Multiple Clerosis Center Nijmegen
Heiweg 97, Nyimegen, Netherlands
Erasmus MC
Dr. Molewaterplein 40, Rotterdam, Netherlands
Sint Elisabeth Ziekenhuis
Hilvarenbeekse Weg 60, Tilburg, Netherlands
Maaslandziekenhuis Sittard
Walramstraat 23, BK Sittard, , Netherlands
Samodzielny Publiczny Szpital Kliniczny
Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A, Bialystok, Poland
Niezalezny Zespol Opieki Zdrowotnej Kendron
Ul. Swietego Mikolaja 1/8, Bialystok, Poland
Oddzial Neurologiczny i Leczenia Udarow
Mozgu, Nowe Ogrody 1/6, Gdańsk, Poland
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
Ul. Medykow 14, Katowice, Poland
Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
Department of Neurology, Ul. Przybyszewskiego 49, Poznan, Poland
CSK MSWiA Hospital
Department of Neurology, Wołoska 137, Warsaw, Poland
Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
II Klinika Neurologii, Ul. Sobieskiego 1/9, Warsaw, Poland
Centralny Szpital Kliniczny, Klinika Neurologii
MSWiAw Warszawie, Woloska 137, Warszawa, Poland
Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
Ul. Banacha 1A, Warszawa, Poland
Medical University of Lodz
Lodz, , Poland
Interregional Clinical Diagnistic Center, Neurology Department
Kazan', , Russia
Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
Moscow, , Russia
Moscow Regional Research Clinical Institue
Moscow, , Russia
Military Medical Academy, Neurology Department
Saint Petersburg, , Russia
GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
Saint Petersburg, , Russia
II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
Limbová 5, Bratislava Region, Slovakia
Neurologická klinika, Martinská fakultná nemocnica
Kollárova 2, Martin, , Slovakia
I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
Mickiewiczova 13, Bratislava, , Slovakia
Neurologické oddelenie, Nemocnica s poliklinikou Žilina
ul.V. Spanyola 43, Žilina, , Slovakia
Umhlanga Hospital
Umhlanga, KwaZulu-Natal, South Africa
Division of Neurology, Groote Schuur Hospital
E 8-74, Groote Schuur Hospital, Observatory Cape Town, , South Africa
Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
Sandton, , South Africa
MS Centrum
Forskningsenhet, SU/Östra CKÖ Plan 0, Gothenburg, Sweden
Karolinska University Hospital Huddinge
Department of Neurology R54, Stockholm, , Sweden
Karolinska University Hospital, Department of Medicine
Neuroimmunology Unit, CMM L8:04, Stockholm, , Sweden
Kantonsspital Basel, Policlinic
Neurology-Neurosurgical, Petersgraben 4, Basel, Switzerland
Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
Rue Du Bugnon, Lausanne, Switzerland
UniversitätsSpital Zürich, Neurologische Klinik
Frauenklinikstr. 26, Zurich, , Switzerland
Hacettepe Universiti Hospitals
Department of Neurology, Ankara, Turkey (Türkiye)
Gazi University
Medical Faculty Neurology Department, Besevler Ankara, Turkey (Türkiye)
EGE University
Medical Faculty Hospital Neurolgy Department, Bornova Izmir, Turkey (Türkiye)
Istanbul University, Istanbul Faculty of Medicine
Departement of Neurology, Capa Istanbul, Turkey (Türkiye)
Istanbul University, Cerrahpasa School of Medicine
Department of Neurology, Cerrahpasa Istanbul, Turkey (Türkiye)
Gaziantep University School of Medicine
Neurology Department, Gaziantep, Turkey (Türkiye)
Uludag University Faculty of Medche
Tip Fakultesi, Noroloji ABD, Görükle / Bursa, Turkey (Türkiye)
Tepecik Training and Research
Hospital Neurology Service, 35120 Gaziler Cad. Izmir, , Turkey (Türkiye)
Dokuz University Medical Faculty, Neurology Department
Inciralti, Izmir, , Turkey (Türkiye)
Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
Istanbul, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Noroloji ABD, Mersin, , Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
Noroloji Klinigi, Göztepe Istanbul, , Turkey (Türkiye)
King's College Hospital, Trials office Academie Neuroscience Center
P041 Institute of Psychiatry, Denmark Hill, London, United Kingdom
Queens Medical Centre
Division of Clinical Neurology Medical School, Nottingham, United Kingdom
Royal Hallamshire Hospital
Glossop Road, Sheffield, United Kingdom
St. George's Hospital, Neurology Dept. Atkinson Morley Wing
Backshaw Road, London, , United Kingdom
Frenchay Hospital, Department of Neurology
Beckspool Road, Bristol, , United Kingdom
Royal Victoria Infirmary
Queen Victoria Road, Newcastle-upon-Tyne, , United Kingdom
Countries
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References
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Nowak CP, Mutze T, Konietschke F. Group sequential methods for the Mann-Whitney parameter. Stat Methods Med Res. 2022 Oct;31(10):2004-2020. doi: 10.1177/09622802221107103. Epub 2022 Jun 13.
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.
Kremenchutzky M, O'Connor P, Hohlfeld R, Zhang-Auberson L, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Kappos L. Impact of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod: Subgroup analyses of the Fingolimod Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study. Mult Scler Relat Disord. 2014 May;3(3):341-9. doi: 10.1016/j.msard.2013.10.006. Epub 2013 Nov 5.
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.
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.
Radue EW, O'Connor P, Polman CH, Hohlfeld R, Calabresi P, Selmaj K, Mueller-Lenke N, Agoropoulou C, Holdbrook F, de Vera A, Zhang-Auberson L, Francis G, Burtin P, Kappos L; FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) Study Group. Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Arch Neurol. 2012 Oct;69(10):1259-69. doi: 10.1001/archneurol.2012.1051.
Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C, Haring DA, Francis G, Kappos L; FREEDOMS study group. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012 May;11(5):420-8. doi: 10.1016/S1474-4422(12)70056-X. Epub 2012 Apr 10.
Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. doi: 10.1056/NEJMoa0909494. Epub 2010 Jan 20.
Related Links
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Fingolimod clinical trials information website
Other Identifiers
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CFTY720D2301
Identifier Type: -
Identifier Source: org_study_id
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