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

April 9, 2012 updated by: Novartis

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to end of study (Month 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to end of study (Month 24)
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.
Baseline to end of study (Month 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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