Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT00289978
- Lead Sponsor
- Novartis
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1272
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fingolimod 1.25 mg Fingolimod 1.25 mg - Fingolimod 0.5 mg Fingolimod 0.5 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Estimated Annualized Aggregate Relapse Rate (ARR) Baseline to end of study (Month 24) The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) Baseline to end of study (Month 24) EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline Baseline to end of study (Month 24) The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Trial Locations
- Locations (98)
Gaziantep University School of Medicine
🇹🇷Neurology Department, Gaziantep, Turkey
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Athens Naval Hospital, Neurology Department
🇬🇷Athens, Greece
Carmel Medical Center
🇮🇱Haifa, Israel
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
St. George's Hospital, Neurology Dept. Atkinson Morley Wing
🇬🇧Backshaw Road, London, United Kingdom
Uludag University Faculty of Medche
🇹🇷Tip Fakultesi, Noroloji ABD, Görükle / Bursa, Turkey
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
Frenchay Hospital, Department of Neurology
🇬🇧Beckspool Road, Bristol, United Kingdom
Royal Victoria Infirmary
🇬🇧Queen Victoria Road, Newcastle-upon-Tyne, United Kingdom
University of Saskatchewan
🇨🇦Regina, Saskatchewan, Canada
Faculty Hospital
🇨🇿Department of Neurology, Alej Svobody 80, Plzeň, Czech Republic
Turku University Hospital, Neurology Department 799
🇫🇮Kiinanmyllynkatu 11- 14, Turku, Finland
Hyvinkään sairaala
🇫🇮Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää, Finland
Kaunas University Hospital Department of Neurology
🇱🇹Eiveniu 2, Kaunas, Lithuania
Academisch Ziekenhuis VU
🇳🇱De Boelelaan 1118, Amsterdam, Netherlands
Sint Elisabeth Ziekenhuis
🇳🇱Hilvarenbeekse Weg 60, Tilburg, Netherlands
Medical University of Lodz
🇵🇱Lodz, Poland
Interregional Clinical Diagnistic Center, Neurology Department
🇷🇺Kazan, Russian Federation
II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
🇸🇰Limbová 5, Bratislava, Slovakia
Neurologická klinika, Martinská fakultná nemocnica
🇸🇰Kollárova 2, Martin, Slovakia
UniversitätsSpital Zürich, Neurologische Klinik
🇨🇭Frauenklinikstr. 26, Zurich, Switzerland
Hacettepe Universiti Hospitals
🇹🇷Department of Neurology, Ankara, Turkey
North Gosford Private Hospital
🇦🇺Burrabil Avenue, Suite 17, Gosford, Australia
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
🇦🇺Fitzroy, Australia
Strategic Health Evaluators
🇦🇺Chatswood, Australia
Algemeen Ziekenhuis St. Jan, Department of Neurology
🇧🇪Ruddershove 10, Brugge, Belgium
Austin Health, Department of Neurology
🇦🇺Heidelberg, Australia
Erasme Hospital
🇧🇪Route de Lennik 808, Brussels, Belgium
CHU Charleroi, Hôpital Civil
🇧🇪Boulevard Paul Janson 92, Charleroi, Belgium
Regionaal Ziekenhuis
🇧🇪St.Trudo, Diestersteenweg 100,, St.Truiden, Belgium
National Multiple Sclerose Centrum v.z.w
🇧🇪Vanheylenstraat 16, Melsbroek, Belgium
DMSRU - Capital Health
🇨🇦Halifax, Nova Scotia, Canada
Kingston General Hospital, MS Clinic
🇨🇦Connell 7, 76 Stuart Street, Kingston, Ontario, Canada
Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
🇨🇦Montreal, Quebec, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Nepean Medical Center
🇨🇦Ottawa, Ontario, Canada
Clinical Trials Office,
🇨🇦Trillium Health Center, 00 Queesway West, Mississauga, Ontario, Canada
Military Hospital of Brno
🇨🇿Department of Neurology, Zabrdovicka 3, Brno, Czech Republic
Faculty Hospital Motol, MS Center
🇨🇿Department of Neurology, V Uvalu 84, Prague 5, Czech Republic
Faculty Hospital St. Anne
🇨🇿First Department of Neurology, Pekarska 53, Brno, Czech Republic
Centrum neurologicke pece
🇨🇿Jiraskova 1389, Rychnov nad Kneznou, Czech Republic
Vseobecna fakultni nemocnice
🇨🇿MS Centrum, Neurologicka klinika, Karlovo namesti 32, Praha 2, Czech Republic
MS Centrum
🇸🇪Forskningsenhet, SU/Östra CKÖ plan 0, Gothenburg, Sweden
Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
🇨🇿Ostrava, Czech Republic
Helsinki Headache Center Postitalon Lääkäriasema
🇫🇮Mannnerheiminaukio 1 B 2 Floor, Helsinki, Finland
CHU La Timone
🇫🇷Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5, France
Investigational Site
🇩🇪Wurzburg, Germany
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
St. Antonius Ziekenhuis
🇳🇱Postbus 2500, Nieuwegein, Netherlands
Samodzielny Publiczny Szpital Kliniczny
🇵🇱Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A, Bialystok, Poland
Maaslandziekenhuis Sittard
🇳🇱Walramstraat 23, BK Sittard, Netherlands
Niezalezny Zespol Opieki Zdrowotnej Kendron
🇵🇱Ul. Swietego Mikolaja 1/8, Bialystok, Poland
Oddzial Neurologiczny i Leczenia Udarow
🇵🇱Mozgu, Nowe Ogrody 1/6, Gdańsk, Poland
Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
🇵🇱Department of Neurology, ul. Przybyszewskiego 49, Poznan, Poland
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
🇵🇱ul. Medykow 14, Katowice, Poland
Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
🇷🇺Moscow, Russian Federation
GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
🇷🇺St-Petersburg, Russian Federation
Moscow Regional Research Clinical Institue
🇷🇺Moscow, Russian Federation
Military Medical Academy, Neurology Department
🇷🇺St. Petersburg, Russian Federation
Karolinska University Hospital Huddinge
🇸🇪Department Of Neurology R54, Stockholm, Sweden
Division of Neurology, Groote Schuur Hospital
🇿🇦E 8-74, Groote Schuur Hospital, Observatory Cape Town, South Africa
Neurologické oddelenie, Nemocnica s poliklinikou Žilina
🇸🇰ul.V. Spanyola 43, Žilina, Slovakia
Umhlanga Hospital
🇿🇦Umhlanga, KZN, South Africa
Karolinska University Hospital, Department of Medicine
🇸🇪Neuroimmunology unit, CMM L8:04, Stockholm, Sweden
Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
🇿🇦Sandton, South Africa
Gazi University
🇹🇷Medical Faculty Neurology Department, Besevler Ankara, Turkey
Tepecik Training and Research
🇹🇷Hospital Neurology Service, 35120 Gaziler Cad. Izmir, Turkey
EGE University
🇹🇷Medical Faculty Hospital Neurolgy Department, Bornova Izmir, Turkey
Istanbul University, Istanbul Faculty of Medicine
🇹🇷Departement of Neurology, Capa Istanbul, Turkey
Istanbul University, Cerrahpasa School of Medicine
🇹🇷Department of Neurology, Cerrahpasa Istanbul, Turkey
Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
🇹🇷Istanbul, Turkey
Dokuz University Medical Faculty, Neurology Department
🇹🇷Inciralti, Izmir, Turkey
Mersin Universitesi Tip Fakultesi Hastanesi
🇹🇷Noroloji ABD, Mersin, Turkey
T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
🇹🇷Noroloji Klinigi, Göztepe Istanbul, Turkey
Sieff Medical Center
🇮🇱Safed, Israel
Sheba - Medical Center
🇮🇱Tel Hashomer, Ramat-Gan,, Israel
University Hospital Gasthuisberg
🇧🇪Department Neurology, Herestraat 49, Leuven, Belgium
MS Klinik
🇧🇪Boemerangstraat 2, Overpelt, Belgium
Neurologicka klinika, Fakultni nemocnice
🇨🇿Kralovske Vinohrady, Srobarova 50, Praha, Czech Republic
Finnish Special Neurology Center Ltd.
🇫🇮Brahenkatu 11 D,, Turku, Finland
Hospital of Pardubice
🇨🇿Department of Neurology, Kyjevska 44, Pardubice, Czech Republic
AZ Alma
🇧🇪Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, Belgium
Suomen Terveystalo/ Päänsärkykeskus, Tampere
🇫🇮Hämeenkatu 18, 6th fl., Tampere, Finland
Multiple Clerosis Center Nijmegen
🇳🇱Heiweg 97, Nyimegen, Netherlands
CSK MSWiA Hospital
🇵🇱Department of Neurology, Wołoska 137, Warsaw, Poland
Erasmus MC
🇳🇱Dr. Molewaterplein 40, Rotterdam, Netherlands
University of British Columbia
🇨🇦ME498 2211 Wesbrook Mall, Vancouver, British Columbia, Canada
I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
🇸🇰Mickiewiczova 13, Bratislava, Slovakia
Kantonsspital Basel, Policlinic
🇨🇭Neurology-Neurosurgical, Petersgraben 4, Basel, Switzerland
Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
🇨🇭Rue du Bugnon, Lausanne, Switzerland
Royal Hallamshire Hospital
🇬🇧Glossop Road, Sheffield, United Kingdom