Clinical trial NCT00289978: Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Official title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
FTY720
Fingolimod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 1272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)


Eligibility criteria: Inclusion Criteria:

* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
* Patients with a relapsing-remitting disease course
* Patients with EDSS score of 0-5.5

Exclusion Criteria:

* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.

Primary outcomes:
measure: Estimated Annualized Aggregate Relapse Rate (ARR)
timeFrame: Baseline to end of study (Month 24)
Secondary outcomes:
measure: Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
timeFrame: Baseline to end of study (Month 24)
measure: Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
timeFrame: Baseline to end of study (Month 24)
Other outcomes:
Locations:
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Burrabil Avenue, Suite 17, Gosford
country: Australia
facility: North Gosford Private Hospital
city: Chatswood
country: Australia
facility: Strategic Health Evaluators
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
city: Heidelberg
country: Australia
facility: Austin Health, Department of Neurology
city: Ruddershove 10
country: Belgium
facility: Algemeen Ziekenhuis St. Jan, Department of Neurology
state: Brugge
city: Route de Lennik 808
country: Belgium
facility: Erasme Hospital
state: Brussels
city: Boulevard Paul Janson 92
country: Belgium
facility: CHU Charleroi, Hôpital Civil
state: Charleroi
city: Department Neurology, Herestraat 49
country: Belgium
facility: University Hospital Gasthuisberg
state: Leuven
city: Department of Neurology & Rehab-Umit, Gentsesteenweg 132
country: Belgium
facility: AZ Alma
state: Sijsele
city: St.Trudo, Diestersteenweg 100,
country: Belgium
facility: Regionaal Ziekenhuis
state: St.Truiden
city: Boemerangstraat 2, Overpelt
country: Belgium
facility: MS Klinik
city: Vanheylenstraat 16, Melsbroek
country: Belgium
facility: National Multiple Sclerose Centrum v.z.w
city: ME498 2211 Wesbrook Mall, Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: DMSRU - Capital Health
state: Nova Scotia
city: Connell 7, 76 Stuart Street, Kingston
country: Canada
facility: Kingston General Hospital, MS Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Nepean Medical Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Trillium Health Center, 00 Queesway West, Mississauga
country: Canada
facility: Clinical Trials Office,
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
state: Quebec
city: Regina
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Department of Neurology, Zabrdovicka 3
country: Czech Republic
facility: Military Hospital of Brno
state: Brno
city: First Department of Neurology, Pekarska 53
country: Czech Republic
facility: Faculty Hospital St. Anne
state: Brno
city: Department of Neurology, I.P. Paulova 6
country: Czech Republic
facility: Faculty Hospital
state: Olomouc
city: Department of Neurology, Kyjevska 44
country: Czech Republic
facility: Hospital of Pardubice
state: Pardubice
city: Department of Neurology, Alej Svobody 80
country: Czech Republic
facility: Faculty Hospital
state: Plzeň
city: Department of Neurology, V Uvalu 84
country: Czech Republic
facility: Faculty Hospital Motol, MS Center
state: Prague 5
city: MS Centrum, Neurologicka klinika, Karlovo namesti 32
country: Czech Republic
facility: Vseobecna fakultni nemocnice
state: Praha 2
city: Kralovske Vinohrady, Srobarova 50
country: Czech Republic
facility: Neurologicka klinika, Fakultni nemocnice
state: Praha
city: Neurology Department of Hospital Teplice, Duchcovska 53
country: Czech Republic
facility: MS Centrum
state: Teplice
city: Jiraskova 1389, Rychnov nad Kneznou
country: Czech Republic
facility: Centrum neurologicke pece
city: Ostrava
country: Czech Republic
facility: Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
city: Mannnerheiminaukio 1 B 2 Floor
country: Finland
facility: Helsinki Headache Center Postitalon Lääkäriasema
state: Helsinki
city: Brahenkatu 11 D,
country: Finland
facility: Finnish Special Neurology Center Ltd.
state: Turku
city: Hämeenkatu 18, 6th fl., Tampere
country: Finland
facility: Suomen Terveystalo/ Päänsärkykeskus, Tampere
city: Kiinanmyllynkatu 11- 14, Turku
country: Finland
facility: Turku University Hospital, Neurology Department 799
city: Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää
country: Finland
facility: Hyvinkään sairaala
city: Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5
country: France
facility: CHU La Timone
city: Berlin
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Dusseldorf
country: Germany
facility: Investigational Site
city: Giessen
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Leipzig
country: Germany
facility: Investigational Site
city: Magdeburg
country: Germany
facility: Investigational Site
city: Munchen
country: Germany
facility: Investigational Site
city: Munchen
country: Germany
facility: Investigational Site
city: Munster
country: Germany
facility: Investigational Site
city: Regensburg
country: Germany
facility: Investigational Site
city: Seesen/Harz
country: Germany
facility: Investigational Site
city: Stuttgart
country: Germany
facility: Investigational Site
city: Tubingen
country: Germany
facility: Investigational Site
city: Wurzburg
country: Germany
facility: Investigational Site
city: Athens
country: Greece
facility: Athens Naval Hospital, Neurology Department
city: Mesogeion 154 Ave., Athens
country: Greece
facility: Neurology Department Athens General Hospital, G. Gennimatas
city: Terma Zaimi, Melissia-Athens
country: Greece
facility: 1st IKA Papadimitriou Neurology Dept
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Safed
country: Israel
facility: Sieff Medical Center
city: Tel Hashomer, Ramat-Gan,
country: Israel
facility: Sheba - Medical Center
city: Eiveniu 2, Kaunas
country: Lithuania
facility: Kaunas University Hospital Department of Neurology
city: De Boelelaan 1118
country: Netherlands
facility: Academisch Ziekenhuis VU
state: Amsterdam
city: Postbus 2500
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Nieuwegein
city: Heiweg 97
country: Netherlands
facility: Multiple Clerosis Center Nijmegen
state: Nyimegen
city: Dr. Molewaterplein 40
country: Netherlands
facility: Erasmus MC
state: Rotterdam
city: Hilvarenbeekse Weg 60
country: Netherlands
facility: Sint Elisabeth Ziekenhuis
state: Tilburg
city: Walramstraat 23, BK Sittard
country: Netherlands
facility: Maaslandziekenhuis Sittard
city: Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
state: Bialystok
city: Ul. Swietego Mikolaja 1/8
country: Poland
facility: Niezalezny Zespol Opieki Zdrowotnej Kendron
state: Bialystok
city: Mozgu, Nowe Ogrody 1/6
country: Poland
facility: Oddzial Neurologiczny i Leczenia Udarow
state: Gdańsk
city: ul. Medykow 14
country: Poland
facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
state: Katowice
city: Department of Neurology, ul. Przybyszewskiego 49
country: Poland
facility: Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
state: Poznan
city: Department of Neurology, Wołoska 137
country: Poland
facility: CSK MSWiA Hospital
state: Warsaw
city: II Klinika Neurologii, ul. Sobieskiego 1/9
country: Poland
facility: Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
state: Warsaw
city: MSWiAw Warszawie, Woloska 137
country: Poland
facility: Centralny Szpital Kliniczny, Klinika Neurologii
state: Warszawa
city: ul. Banacha 1A
country: Poland
facility: Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
state: Warszawa
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Kazan
country: Russian Federation
facility: Interregional Clinical Diagnistic Center, Neurology Department
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Clinical Institue
city: St-Petersburg
country: Russian Federation
facility: GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
city: St. Petersburg
country: Russian Federation
facility: Military Medical Academy, Neurology Department
city: Limbová 5
country: Slovakia
facility: II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
state: Bratislava
city: Kollárova 2, Martin
country: Slovakia
facility: Neurologická klinika, Martinská fakultná nemocnica
city: Mickiewiczova 13, Bratislava
country: Slovakia
facility: I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
city: ul.V. Spanyola 43, Žilina
country: Slovakia
facility: Neurologické oddelenie, Nemocnica s poliklinikou Žilina
city: Umhlanga
country: South Africa
facility: Umhlanga Hospital
state: KZN
city: E 8-74, Groote Schuur Hospital, Observatory Cape Town
country: South Africa
facility: Division of Neurology, Groote Schuur Hospital
city: Sandton
country: South Africa
facility: Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
city: Forskningsenhet, SU/Östra CKÖ plan 0
country: Sweden
facility: MS Centrum
state: Gothenburg
city: Department Of Neurology R54, Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Neuroimmunology unit, CMM L8:04, Stockholm
country: Sweden
facility: Karolinska University Hospital, Department of Medicine
city: Neurology-Neurosurgical, Petersgraben 4
country: Switzerland
facility: Kantonsspital Basel, Policlinic
state: Basel
city: Rue du Bugnon
country: Switzerland
facility: Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
state: Lausanne
city: Frauenklinikstr. 26, Zurich
country: Switzerland
facility: UniversitätsSpital Zürich, Neurologische Klinik
city: Department of Neurology
country: Turkey
facility: Hacettepe Universiti Hospitals
state: Ankara
city: Medical Faculty Neurology Department
country: Turkey
facility: Gazi University
state: Besevler Ankara
city: Medical Faculty Hospital Neurolgy Department
country: Turkey
facility: EGE University
state: Bornova Izmir
city: Departement of Neurology
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
state: Capa Istanbul
city: Department of Neurology
country: Turkey
facility: Istanbul University, Cerrahpasa School of Medicine
state: Cerrahpasa Istanbul
city: Neurology Department
country: Turkey
facility: Gaziantep University School of Medicine
state: Gaziantep
city: Tip Fakultesi, Noroloji ABD
country: Turkey
facility: Uludag University Faculty of Medche
state: Görükle / Bursa
city: Hospital Neurology Service, 35120 Gaziler Cad. Izmir
country: Turkey
facility: Tepecik Training and Research
city: Inciralti, Izmir
country: Turkey
facility: Dokuz University Medical Faculty, Neurology Department
city: Istanbul
country: Turkey
facility: Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
city: Noroloji ABD, Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
city: Noroloji Klinigi, Göztepe Istanbul
country: Turkey
facility: T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
city: P041 Institute of Psychiatry, Denmark Hill
country: United Kingdom
facility: King's College Hospital, Trials office Academie Neuroscience Center
state: London
city: Division of Clinical Neurology Medical School
country: United Kingdom
facility: Queens Medical Centre
state: Nottingham
city: Glossop Road
country: United Kingdom
facility: Royal Hallamshire Hospital
state: Sheffield
city: Backshaw Road, London
country: United Kingdom
facility: St. George's Hospital, Neurology Dept. Atkinson Morley Wing
city: Beckspool Road, Bristol
country: United Kingdom
facility: Frenchay Hospital, Department of Neurology
city: Queen Victoria Road, Newcastle-upon-Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.