Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
FREEDOMS
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
1 other identifier
interventional
1,272
19 countries
115
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2006
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
March 16, 2011
CompletedApril 11, 2012
April 1, 2012
3.5 years
February 9, 2006
January 4, 2011
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimated Annualized Aggregate Relapse Rate (ARR)
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.
Baseline to end of study (Month 24)
Secondary Outcomes (2)
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)
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
Baseline to end of study (Month 24)
Study Arms (3)
Fingolimod 1.25 mg
EXPERIMENTALFingolimod 0.5 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (115)
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
North Gosford Private Hospital
Burrabil Avenue, Suite 17, Gosford, NSW 2250, Australia
Strategic Health Evaluators
Chatswood, 2067, Australia
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
Fitzroy, 3065 VIC, Australia
Austin Health, Department of Neurology
Heidelberg, 3084, Australia
Algemeen Ziekenhuis St. Jan, Department of Neurology
Ruddershove, Brugge, 8000, Belgium
Erasme Hospital
Route de Lennik 808, Brussels Capital, 1070, Belgium
CHU Charleroi, Hôpital Civil
Boulevard Paul Janson 92, Charleroi, 6000, Belgium
University Hospital Gasthuisberg
Department Neurology, Herestraat 49, Leuven, 3000, Belgium
AZ Alma
Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, 8340, Belgium
Regionaal Ziekenhuis
St.Trudo, Diestersteenweg 100,, St.Truiden, 3800, Belgium
MS Klinik
Boemerangstraat 2, Overpelt, 3900, Belgium
National Multiple Sclerose Centrum v.z.w
Vanheylenstraat 16, Melsbroek, 1820, Belgium
University of British Columbia
Me498 2211 Wesbrook Mall, Vancouver, British Columbia, V6T 2B5, Canada
DMSRU - Capital Health
Halifax, Nova Scotia, Canada
Kingston General Hospital, MS Clinic
Connell 7, 76 Stuart Street, Kingston, Ontario, K7L 2V7, Canada
Nepean Medical Center
Ottawa, Ontario, K2G 6E2, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Clinical Trials Office,
Trillium Health Center, 00 Queesway West, Mississauga, Ontario, L5B 1B8, Canada
Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
Montreal, Quebec, H1T 2M4, Canada
University of Saskatchewan
Regina, Saskatchewan, S4T 1A5, Canada
Military Hospital of Brno
Department of Neurology, Zabrdovicka 3, Brno, 63600, Czechia
Faculty Hospital St. Anne
First Department of Neurology, Pekarska 53, Brno, 65691, Czechia
Faculty Hospital
Department of Neurology, I.P. Paulova 6, Olomouc, 77520, Czechia
Hospital of Pardubice
Department of Neurology, Kyjevska 44, Pardubice, 53203, Czechia
Faculty Hospital
Department of Neurology, Alej Svobody 80, Plzeň, 3046, Czechia
Neurologicka klinika, Fakultni nemocnice
Kralovske Vinohrady, Srobarova 50, Prague, 10034, Czechia
Faculty Hospital Motol, MS Center
Department of Neurology, V Uvalu 84, Prague 5, 15006, Czechia
Vseobecna fakultni nemocnice
MS Centrum, Neurologicka Klinika, Karlovo Namesti 32, Praha 2, 12808, Czechia
MS Centrum
Neurology Department of Hospital Teplice, Duchcovska 53, Teplice, 41529, Czechia
Centrum neurologicke pece
Jiraskova 1389, Rychnov Nad Kneznou, 51601, Czechia
Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
Ostrava, 70852, Czechia
Helsinki Headache Center Postitalon Lääkäriasema
Mannnerheiminaukio 1 B 2 Floor, Helsinki, 0100, Finland
Finnish Special Neurology Center Ltd.
Brahenkatu 11 D,, Turku, 20100, Finland
Suomen Terveystalo/ Päänsärkykeskus, Tampere
Hämeenkatu 18, 6th Fl., Tampere, 33200, Finland
Turku University Hospital, Neurology Department 799
Kiinanmyllynkatu 11- 14, Turku, 20520, Finland
Hyvinkään sairaala
Neurologian Poliklinikka, Sairaalankatu 1, Hyvinkää, 05850, Finland
CHU La Timone
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5, 13385, France
Investigational Site
Berlin, 10117, Germany
Investigational Site
Berlin, 13347, Germany
Investigational Site
Düsseldorf, 40225, Germany
Investigational Site
Giessen, 35385, Germany
Investigational Site
Hamburg, 20099, Germany
Investigational Site
Hamburg, 20246, Germany
Investigational Site
Leipzig, 04103, Germany
Investigational Site
Magdeburg, 39120, Germany
Investigational Site
München, 80331, Germany
Investigational Site
München, 81377, Germany
Investigational Site
Münster, 48149, Germany
Investigational Site
Regensburg, 93053, Germany
Investigational Site
Seesen/Harz, 38723, Germany
Investigational Site
Stuttgart, 70191, Germany
Investigational Site
Tübingen, 72076, Germany
Investigational Site
Würzburg, 97080, Germany
Athens Naval Hospital, Neurology Department
Athens, 11521, Greece
Neurology Department Athens General Hospital, G. Gennimatas
Mesogeion 154 Ave., Athens, 11527, Greece
1st IKA Papadimitriou Neurology Dept
Terma Zaimi, Melissia-Athens, 15127, Greece
University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
Thessaloniki, 54636, Greece
Barzilai Medical Center
Ashkelon, 78306, Israel
Carmel Medical Center
Haifa, 34362, Israel
Sieff Medical Center
Safed, 13100, Israel
Sheba - Medical Center
Tel Hashomer, Ramat-Gan,, 52621, Israel
Kaunas University Hospital Department of Neurology
Eiveniu 2, Kaunas, LY-50009, Lithuania
Academisch Ziekenhuis VU
De Boelelaan 1118, Amsterdam, 1081, Netherlands
St. Antonius Ziekenhuis
Postbus 2500, Nieuwegein, 3430 EM, Netherlands
Multiple Clerosis Center Nijmegen
Heiweg 97, Nyimegen, 6533, Netherlands
Erasmus MC
Dr. Molewaterplein 40, Rotterdam, 3015 GD, Netherlands
Sint Elisabeth Ziekenhuis
Hilvarenbeekse Weg 60, Tilburg, 5022, Netherlands
Maaslandziekenhuis Sittard
Walramstraat 23, BK Sittard, 6131, Netherlands
Samodzielny Publiczny Szpital Kliniczny
Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A, Bialystok, 15-276, Poland
Niezalezny Zespol Opieki Zdrowotnej Kendron
Ul. Swietego Mikolaja 1/8, Bialystok, 15-420, Poland
Oddzial Neurologiczny i Leczenia Udarow
Mozgu, Nowe Ogrody 1/6, Gdańsk, 80-803, Poland
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
Ul. Medykow 14, Katowice, 40-752, Poland
Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
Department of Neurology, Ul. Przybyszewskiego 49, Poznan, 60-355, Poland
CSK MSWiA Hospital
Department of Neurology, Wołoska 137, Warsaw, 02-507, Poland
Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
II Klinika Neurologii, Ul. Sobieskiego 1/9, Warsaw, 02-957, Poland
Centralny Szpital Kliniczny, Klinika Neurologii
MSWiAw Warszawie, Woloska 137, Warszawa, 00-909, Poland
Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
Ul. Banacha 1A, Warszawa, 01-097, Poland
Medical University of Lodz
Lodz, Poland
Interregional Clinical Diagnistic Center, Neurology Department
Kazan', 420111, Russia
Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
Moscow, 121356, Russia
Moscow Regional Research Clinical Institue
Moscow, 129110, Russia
Military Medical Academy, Neurology Department
Saint Petersburg, 194044, 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, 833 05, Slovakia
Neurologická klinika, Martinská fakultná nemocnica
Kollárova 2, Martin, 03659, Slovakia
I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
Mickiewiczova 13, Bratislava, 813 69, Slovakia
Neurologické oddelenie, Nemocnica s poliklinikou Žilina
ul.V. Spanyola 43, Žilina, 012 07, Slovakia
Umhlanga Hospital
Umhlanga, KwaZulu-Natal, 4319, South Africa
Division of Neurology, Groote Schuur Hospital
E 8-74, Groote Schuur Hospital, Observatory Cape Town, 7925, South Africa
Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
Sandton, 2196, South Africa
MS Centrum
Forskningsenhet, SU/Östra CKÖ Plan 0, Gothenburg, 41345, Sweden
Karolinska University Hospital Huddinge
Department of Neurology R54, Stockholm, 14186, Sweden
Karolinska University Hospital, Department of Medicine
Neuroimmunology Unit, CMM L8:04, Stockholm, 171 76, Sweden
Kantonsspital Basel, Policlinic
Neurology-Neurosurgical, Petersgraben 4, Basel, 4031, Switzerland
Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
Rue Du Bugnon, Lausanne, 1011, Switzerland
UniversitätsSpital Zürich, Neurologische Klinik
Frauenklinikstr. 26, Zurich, 8091, Switzerland
Hacettepe Universiti Hospitals
Department of Neurology, Ankara, Turkey (Türkiye)
Gazi University
Medical Faculty Neurology Department, Besevler Ankara, 06500, Turkey (Türkiye)
EGE University
Medical Faculty Hospital Neurolgy Department, Bornova Izmir, 35100, Turkey (Türkiye)
Istanbul University, Istanbul Faculty of Medicine
Departement of Neurology, Capa Istanbul, 34093, Turkey (Türkiye)
Istanbul University, Cerrahpasa School of Medicine
Department of Neurology, Cerrahpasa Istanbul, 34098, Turkey (Türkiye)
Gaziantep University School of Medicine
Neurology Department, Gaziantep, 27070, 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, 35340, Turkey (Türkiye)
Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
Istanbul, 34147, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Noroloji ABD, Mersin, 33079, Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
Noroloji Klinigi, Göztepe Istanbul, 34722, Turkey (Türkiye)
King's College Hospital, Trials office Academie Neuroscience Center
P041 Institute of Psychiatry, Denmark Hill, London, SES 8AF, United Kingdom
Queens Medical Centre
Division of Clinical Neurology Medical School, Nottingham, NG7 24H, United Kingdom
Royal Hallamshire Hospital
Glossop Road, Sheffield, S102JF, United Kingdom
St. George's Hospital, Neurology Dept. Atkinson Morley Wing
Backshaw Road, London, Tooting London SW17 0QT, United Kingdom
Frenchay Hospital, Department of Neurology
Beckspool Road, Bristol, BS16 1LE, United Kingdom
Royal Victoria Infirmary
Queen Victoria Road, Newcastle-upon-Tyne, NE1 4LP, United Kingdom
Related Publications (9)
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.
PMID: 35698787DERIVEDFox 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.
PMID: 27733070DERIVEDDerfuss 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.
PMID: 26121423DERIVEDKremenchutzky 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.
PMID: 25876471DERIVEDChinea 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.
PMID: 25245812DERIVEDZarbin 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.
PMID: 23531349DERIVEDRadue 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.
PMID: 22751847DERIVEDDevonshire 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.
PMID: 22494956DERIVEDKappos 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.
PMID: 20089952DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
January 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 11, 2012
Results First Posted
March 16, 2011
Record last verified: 2012-04