Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289978
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 16, 2011
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):

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)

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Fingolimod 1.25 mg Drug: Fingolimod 0.5 mg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Fingolimod 1.25 mg Drug: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.

Experimental: Fingolimod 0.5 mg Drug: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.

Placebo Comparator: Placebo Drug: Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.

Primary Outcome Measures :
  1. Estimated Annualized Aggregate Relapse Rate (ARR) [ Time Frame: 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 :
  1. Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) [ Time Frame: 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.

  2. Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289978

  Hide Study Locations
Australia, South Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
North Gosford Private Hospital
Burrabil Avenue, Suite 17, Gosford, Australia, NSW 2250
Strategic Health Evaluators
Chatswood, Australia, 2067
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
Fitzroy, Australia, 3065 VIC
Austin Health, Department of Neurology
Heidelberg, Australia, 3084
Algemeen Ziekenhuis St. Jan, Department of Neurology
Ruddershove 10, Brugge, Belgium, 8000
Erasme Hospital
Route de Lennik 808, Brussels, Belgium, 1070
CHU Charleroi, Hôpital Civil
Boulevard Paul Janson 92, Charleroi, Belgium, 6000
University Hospital Gasthuisberg
Department Neurology, Herestraat 49, Leuven, Belgium, 3000
AZ Alma
Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, Belgium, 8340
Regionaal Ziekenhuis
St.Trudo, Diestersteenweg 100,, St.Truiden, Belgium, 3800
MS Klinik
Boemerangstraat 2, Overpelt, Belgium, 3900
National Multiple Sclerose Centrum v.z.w
Vanheylenstraat 16, Melsbroek, Belgium, 1820
Canada, British Columbia
University of British Columbia
ME498 2211 Wesbrook Mall, Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
DMSRU - Capital Health
Halifax, Nova Scotia, Canada
Canada, Ontario
Kingston General Hospital, MS Clinic
Connell 7, 76 Stuart Street, Kingston, Ontario, Canada, K7L 2V7
Nepean Medical Center
Ottawa, Ontario, Canada, K2G 6E2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Clinical Trials Office,
Trillium Health Center, 00 Queesway West, Mississauga, Ontario, Canada, L5B 1B8
Canada, Quebec
Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
University of Saskatchewan
Regina, Saskatchewan, Canada, S4T 1A5
Czech Republic
Military Hospital of Brno
Department of Neurology, Zabrdovicka 3, Brno, Czech Republic, 63600
Faculty Hospital St. Anne
First Department of Neurology, Pekarska 53, Brno, Czech Republic, 65691
Faculty Hospital
Department of Neurology, I.P. Paulova 6, Olomouc, Czech Republic, 77520
Hospital of Pardubice
Department of Neurology, Kyjevska 44, Pardubice, Czech Republic, 53203
Faculty Hospital
Department of Neurology, Alej Svobody 80, Plzeň, Czech Republic, 3046
Faculty Hospital Motol, MS Center
Department of Neurology, V Uvalu 84, Prague 5, Czech Republic, 15006
Vseobecna fakultni nemocnice
MS Centrum, Neurologicka klinika, Karlovo namesti 32, Praha 2, Czech Republic, 12808
Neurologicka klinika, Fakultni nemocnice
Kralovske Vinohrady, Srobarova 50, Praha, Czech Republic, 10034
MS Centrum
Neurology Department of Hospital Teplice, Duchcovska 53, Teplice, Czech Republic, 41529
Centrum neurologicke pece
Jiraskova 1389, Rychnov nad Kneznou, Czech Republic, 51601
Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department
Ostrava, Czech Republic, 70852
Helsinki Headache Center Postitalon Lääkäriasema
Mannnerheiminaukio 1 B 2 Floor, Helsinki, Finland, 0100
Finnish Special Neurology Center Ltd.
Brahenkatu 11 D,, Turku, Finland, 20100
Suomen Terveystalo/ Päänsärkykeskus, Tampere
Hämeenkatu 18, 6th fl., Tampere, Finland, 33200
Turku University Hospital, Neurology Department 799
Kiinanmyllynkatu 11- 14, Turku, Finland, 20520
Hyvinkään sairaala
Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää, Finland, 05850
CHU La Timone
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5, France, 13385
Investigational Site
Berlin, Germany, 10117
Investigational Site
Berlin, Germany, 13347
Investigational Site
Dusseldorf, Germany, 40225
Investigational Site
Giessen, Germany, 35385
Investigational Site
Hamburg, Germany, 20099
Investigational Site
Hamburg, Germany, 20246
Investigational Site
Leipzig, Germany, 04103
Investigational Site
Magdeburg, Germany, 39120
Investigational Site
Munchen, Germany, 80331
Investigational Site
Munchen, Germany, 81377
Investigational Site
Munster, Germany, 48149
Investigational Site
Regensburg, Germany, 93053
Investigational Site
Seesen/Harz, Germany, 38723
Investigational Site
Stuttgart, Germany, 70191
Investigational Site
Tubingen, Germany, 72076
Investigational Site
Wurzburg, Germany, 97080
Athens Naval Hospital, Neurology Department
Athens, Greece, 11521
Neurology Department Athens General Hospital, G. Gennimatas
Mesogeion 154 Ave., Athens, Greece, 11527
1st IKA Papadimitriou Neurology Dept
Terma Zaimi, Melissia-Athens, Greece, 15127
University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology
Thessaloniki, Greece, 54636
Barzilai Medical Center
Ashkelon, Israel, 78306
Carmel Medical Center
Haifa, Israel, 34362
Sieff Medical Center
Safed, Israel, 13100
Sheba - Medical Center
Tel Hashomer, Ramat-Gan,, Israel, 52621
Kaunas University Hospital Department of Neurology
Eiveniu 2, Kaunas, Lithuania, LY-50009
Academisch Ziekenhuis VU
De Boelelaan 1118, Amsterdam, Netherlands, 1081
St. Antonius Ziekenhuis
Postbus 2500, Nieuwegein, Netherlands, 3430 EM
Multiple Clerosis Center Nijmegen
Heiweg 97, Nyimegen, Netherlands, 6533
Erasmus MC
Dr. Molewaterplein 40, Rotterdam, Netherlands, 3015 GD
Sint Elisabeth Ziekenhuis
Hilvarenbeekse Weg 60, Tilburg, Netherlands, 5022
Maaslandziekenhuis Sittard
Walramstraat 23, BK Sittard, Netherlands, 6131
Samodzielny Publiczny Szpital Kliniczny
Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A, Bialystok, Poland, 15-276
Niezalezny Zespol Opieki Zdrowotnej Kendron
Ul. Swietego Mikolaja 1/8, Bialystok, Poland, 15-420
Oddzial Neurologiczny i Leczenia Udarow
Mozgu, Nowe Ogrody 1/6, Gdańsk, Poland, 80-803
Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
ul. Medykow 14, Katowice, Poland, 40-752
Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,
Department of Neurology, ul. Przybyszewskiego 49, Poznan, Poland, 60-355
CSK MSWiA Hospital
Department of Neurology, Wołoska 137, Warsaw, Poland, 02-507
Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii
II Klinika Neurologii, ul. Sobieskiego 1/9, Warsaw, Poland, 02-957
Centralny Szpital Kliniczny, Klinika Neurologii
MSWiAw Warszawie, Woloska 137, Warszawa, Poland, 00-909
Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie
ul. Banacha 1A, Warszawa, Poland, 01-097
Medical University of Lodz
Lodz, Poland
Russian Federation
Interregional Clinical Diagnistic Center, Neurology Department
Kazan, Russian Federation, 420111
Central Clinical Hospital of Medical Center of Administration of President of Russian Federation
Moscow, Russian Federation, 121356
Moscow Regional Research Clinical Institue
Moscow, Russian Federation, 129110
GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department
St-Petersburg, Russian Federation
Military Medical Academy, Neurology Department
St. Petersburg, Russian Federation, 194044
II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre
Limbová 5, Bratislava, Slovakia, 833 05
Neurologická klinika, Martinská fakultná nemocnica
Kollárova 2, Martin, Slovakia, 03659
I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto
Mickiewiczova 13, Bratislava, Slovakia, 813 69
Neurologické oddelenie, Nemocnica s poliklinikou Žilina
ul.V. Spanyola 43, Žilina, Slovakia, 012 07
South Africa
Umhlanga Hospital
Umhlanga, KZN, South Africa, 4319
Division of Neurology, Groote Schuur Hospital
E 8-74, Groote Schuur Hospital, Observatory Cape Town, South Africa, 7925
Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place
Sandton, South Africa, 2196
MS Centrum
Forskningsenhet, SU/Östra CKÖ plan 0, Gothenburg, Sweden, 41345
Karolinska University Hospital Huddinge
Department Of Neurology R54, Stockholm, Sweden, 14186
Karolinska University Hospital, Department of Medicine
Neuroimmunology unit, CMM L8:04, Stockholm, Sweden, 171 76
Kantonsspital Basel, Policlinic
Neurology-Neurosurgical, Petersgraben 4, Basel, Switzerland, 4031
Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie
Rue du Bugnon, Lausanne, Switzerland, 1011
UniversitätsSpital Zürich, Neurologische Klinik
Frauenklinikstr. 26, Zurich, Switzerland, 8091
Hacettepe Universiti Hospitals
Department of Neurology, Ankara, Turkey
Gazi University
Medical Faculty Neurology Department, Besevler Ankara, Turkey, 06500
EGE University
Medical Faculty Hospital Neurolgy Department, Bornova Izmir, Turkey, 35100
Istanbul University, Istanbul Faculty of Medicine
Departement of Neurology, Capa Istanbul, Turkey, 34093
Istanbul University, Cerrahpasa School of Medicine
Department of Neurology, Cerrahpasa Istanbul, Turkey, 34098
Gaziantep University School of Medicine
Neurology Department, Gaziantep, Turkey, 27070
Uludag University Faculty of Medche
Tip Fakultesi, Noroloji ABD, Görükle / Bursa, Turkey
Tepecik Training and Research
Hospital Neurology Service, 35120 Gaziler Cad. Izmir, Turkey
Dokuz University Medical Faculty, Neurology Department
Inciralti, Izmir, Turkey, 35340
Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi
Istanbul, Turkey, 34147
Mersin Universitesi Tip Fakultesi Hastanesi
Noroloji ABD, Mersin, Turkey, 33079
T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi
Noroloji Klinigi, Göztepe Istanbul, Turkey, 34722
United Kingdom
King's College Hospital, Trials office Academie Neuroscience Center
P041 Institute of Psychiatry, Denmark Hill, London, United Kingdom, SES 8AF
Queens Medical Centre
Division of Clinical Neurology Medical School, Nottingham, United Kingdom, NG7 24H
Royal Hallamshire Hospital
Glossop Road, Sheffield, United Kingdom, S102JF
St. George's Hospital, Neurology Dept. Atkinson Morley Wing
Backshaw Road, London, United Kingdom, Tooting London SW17 0QT
Frenchay Hospital, Department of Neurology
Beckspool Road, Bristol, United Kingdom, BS16 1LE
Royal Victoria Infirmary
Queen Victoria Road, Newcastle-upon-Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Novartis Identifier: NCT00289978     History of Changes
Other Study ID Numbers: CFTY720D2301
First Posted: February 10, 2006    Key Record Dates
Results First Posted: March 16, 2011
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs