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Relapsing-remitting Multiple SclerosisPhase 3FREEDOMSNCT00289978

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

A Phase 3 study testing Fingolimod 1.25 mg and Fingolimod 0.5 mg in people with Relapsing-remitting Multiple Sclerosis, run by Novartis at 115 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Relapsing-remitting Multiple Sclerosis
What is being tested?
Fingolimod 1.25 mg and Fingolimod 0.5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,272 participants
Where
115 sitesin 19 countries
Study dates
Jan 2006to Jul 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

115 sites in 19 countries.

115 sites in 19 countries

Germany16 sites

  • Investigational Site

    Berlin, 10117

  • Investigational Site

    Berlin, 13347

  • Investigational Site

    Düsseldorf, 40225

  • Investigational Site

    Giessen, 35385

  • Investigational Site

    Hamburg, 20099

  • Investigational Site

    Hamburg, 20246

  • Investigational Site

    Leipzig, 04103

  • Investigational Site

    Magdeburg, 39120

  • Investigational Site

    München, 80331

  • Investigational Site

    München, 81377

  • Investigational Site

    Münster, 48149

  • Investigational Site

    Regensburg, 93053

  • Investigational Site

    Seesen/Harz, 38723

  • Investigational Site

    Stuttgart, 70191

  • Investigational Site

    Tübingen, 72076

  • Investigational Site

    Würzburg, 97080

Other trials in Germany

Turkey (Türkiye)12 sites

  • Istanbul University, Istanbul Faculty of Medicine

    Departement of Neurology, Capa Istanbul, 34093

  • Hacettepe Universiti Hospitals

    Department of Neurology, Ankara

  • Istanbul University, Cerrahpasa School of Medicine

    Department of Neurology, Cerrahpasa Istanbul, 34098

  • Tepecik Training and Research

    Hospital Neurology Service, 35120 Gaziler Cad. Izmir

  • Dokuz University Medical Faculty, Neurology Department

    Inciralti, Izmir, 35340

  • Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi

    Istanbul, 34147

  • EGE University

    Medical Faculty Hospital Neurolgy Department, Bornova Izmir, 35100

  • Gazi University

    Medical Faculty Neurology Department, Besevler Ankara, 06500

  • Gaziantep University School of Medicine

    Neurology Department, Gaziantep, 27070

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Noroloji ABD, Mersin, 33079

  • T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi

    Noroloji Klinigi, Göztepe Istanbul, 34722

  • Uludag University Faculty of Medche

    Tip Fakultesi, Noroloji ABD, Görükle / Bursa

Other trials in Turkey (Türkiye)

Czechia11 sites

  • Faculty Hospital

    Department of Neurology, Alej Svobody 80, Plzeň, 3046

  • Faculty Hospital

    Department of Neurology, I.P. Paulova 6, Olomouc, 77520

  • Hospital of Pardubice

    Department of Neurology, Kyjevska 44, Pardubice, 53203

  • Faculty Hospital Motol, MS Center

    Department of Neurology, V Uvalu 84, Prague 5, 15006

  • Military Hospital of Brno

    Department of Neurology, Zabrdovicka 3, Brno, 63600

  • Faculty Hospital St. Anne

    First Department of Neurology, Pekarska 53, Brno, 65691

  • Centrum neurologicke pece

    Jiraskova 1389, Rychnov Nad Kneznou, 51601

  • Neurologicka klinika, Fakultni nemocnice

    Kralovske Vinohrady, Srobarova 50, Prague, 10034

  • Vseobecna fakultni nemocnice

    MS Centrum, Neurologicka Klinika, Karlovo Namesti 32, Praha 2, 12808

  • MS Centrum

    Neurology Department of Hospital Teplice, Duchcovska 53, Teplice, 41529

  • Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department

    Ostrava, 70852

Other trials in Czechia

Poland10 sites

  • Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,

    Department of Neurology, Ul. Przybyszewskiego 49, Poznan, 60-355

  • CSK MSWiA Hospital

    Department of Neurology, Wołoska 137, Warsaw, 02-507

  • Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii

    II Klinika Neurologii, Ul. Sobieskiego 1/9, Warsaw, 02-957

  • Samodzielny Publiczny Szpital Kliniczny

    Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A, Bialystok, 15-276

  • Medical University of Lodz

    Lodz

  • Oddzial Neurologiczny i Leczenia Udarow

    Mozgu, Nowe Ogrody 1/6, Gdańsk, 80-803

  • Centralny Szpital Kliniczny, Klinika Neurologii

    MSWiAw Warszawie, Woloska 137, Warszawa, 00-909

  • Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie

    Ul. Banacha 1A, Warszawa, 01-097

  • Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

    Ul. Medykow 14, Katowice, 40-752

  • Niezalezny Zespol Opieki Zdrowotnej Kendron

    Ul. Swietego Mikolaja 1/8, Bialystok, 15-420

Other trials in Poland

Belgium8 sites

  • MS Klinik

    Boemerangstraat 2, Overpelt, 3900

  • CHU Charleroi, Hôpital Civil

    Boulevard Paul Janson 92, Charleroi, 6000

  • University Hospital Gasthuisberg

    Department Neurology, Herestraat 49, Leuven, 3000

  • AZ Alma

    Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, 8340

  • Erasme Hospital

    Route de Lennik 808, Brussels Capital, 1070

  • Algemeen Ziekenhuis St. Jan, Department of Neurology

    Ruddershove, Brugge, 8000

  • Regionaal Ziekenhuis

    St.Trudo, Diestersteenweg 100,, St.Truiden, 3800

  • National Multiple Sclerose Centrum v.z.w

    Vanheylenstraat 16, Melsbroek, 1820

Other trials in Belgium

Canada8 sites

  • Kingston General Hospital, MS Clinic

    Connell 7, 76 Stuart Street, Kingston, Ontario, K7L 2V7

  • DMSRU - Capital Health

    Halifax, Nova Scotia

  • University of British Columbia

    Me498 2211 Wesbrook Mall, Vancouver, British Columbia, V6T 2B5

  • Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie

    Montreal, Quebec, H1T 2M4

  • Nepean Medical Center

    Ottawa, Ontario, K2G 6E2

  • University of Saskatchewan

    Regina, Saskatchewan, S4T 1A5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Clinical Trials Office,

    Trillium Health Center, 00 Queesway West, Mississauga, Ontario, L5B 1B8

Other trials in Canada

Netherlands6 sites

  • Academisch Ziekenhuis VU

    De Boelelaan 1118, Amsterdam, 1081

  • Erasmus MC

    Dr. Molewaterplein 40, Rotterdam, 3015 GD

  • Multiple Clerosis Center Nijmegen

    Heiweg 97, Nyimegen, 6533

  • Sint Elisabeth Ziekenhuis

    Hilvarenbeekse Weg 60, Tilburg, 5022

  • St. Antonius Ziekenhuis

    Postbus 2500, Nieuwegein, 3430 EM

  • Maaslandziekenhuis Sittard

    Walramstraat 23, BK Sittard, 6131

Other trials in Netherlands

United Kingdom6 sites

  • St. George's Hospital, Neurology Dept. Atkinson Morley Wing

    Backshaw Road, London, Tooting London SW17 0QT

  • Frenchay Hospital, Department of Neurology

    Beckspool Road, Bristol, BS16 1LE

  • Queens Medical Centre

    Division of Clinical Neurology Medical School, Nottingham, NG7 24H

  • Royal Hallamshire Hospital

    Glossop Road, Sheffield, S102JF

  • King's College Hospital, Trials office Academie Neuroscience Center

    P041 Institute of Psychiatry, Denmark Hill, London, SES 8AF

  • Royal Victoria Infirmary

    Queen Victoria Road, Newcastle-upon-Tyne, NE1 4LP

Other trials in United Kingdom

Australia5 sites

  • North Gosford Private Hospital

    Burrabil Avenue, Suite 17, Gosford, NSW 2250

  • Strategic Health Evaluators

    Chatswood, 2067

  • St Vincent's Hospital Melbourne, Department of Clinical Neurosciences

    Fitzroy, 3065 VIC

  • Austin Health, Department of Neurology

    Heidelberg, 3084

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Finland5 sites

  • Finnish Special Neurology Center Ltd.

    Brahenkatu 11 D,, Turku, 20100

  • Suomen Terveystalo/ Päänsärkykeskus, Tampere

    Hämeenkatu 18, 6th Fl., Tampere, 33200

  • Turku University Hospital, Neurology Department 799

    Kiinanmyllynkatu 11- 14, Turku, 20520

  • Helsinki Headache Center Postitalon Lääkäriasema

    Mannnerheiminaukio 1 B 2 Floor, Helsinki, 0100

  • Hyvinkään sairaala

    Neurologian Poliklinikka, Sairaalankatu 1, Hyvinkää, 05850

Other trials in Finland

Russia5 sites

  • Interregional Clinical Diagnistic Center, Neurology Department

    Kazan', 420111

  • Central Clinical Hospital of Medical Center of Administration of President of Russian Federation

    Moscow, 121356

  • Moscow Regional Research Clinical Institue

    Moscow, 129110

  • Military Medical Academy, Neurology Department

    Saint Petersburg, 194044

  • GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department

    Saint Petersburg

Other trials in Russia

Greece4 sites

  • Athens Naval Hospital, Neurology Department

    Athens, 11521

  • Neurology Department Athens General Hospital, G. Gennimatas

    Mesogeion 154 Ave., Athens, 11527

  • 1st IKA Papadimitriou Neurology Dept

    Terma Zaimi, Melissia-Athens, 15127

  • University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology

    Thessaloniki, 54636

Other trials in Greece

Israel4 sites

  • Barzilai Medical Center

    Ashkelon, 78306

  • Carmel Medical Center

    Haifa, 34362

  • Sieff Medical Center

    Safed, 13100

  • Sheba - Medical Center

    Tel Hashomer, Ramat-Gan,, 52621

Other trials in Israel

Slovakia4 sites

  • Neurologická klinika, Martinská fakultná nemocnica

    Kollárova 2, Martin, 03659

  • II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre

    Limbová 5, Bratislava Region, 833 05

  • I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto

    Mickiewiczova 13, Bratislava, 813 69

  • Neurologické oddelenie, Nemocnica s poliklinikou Žilina

    ul.V. Spanyola 43, Žilina, 012 07

Other trials in Slovakia

South Africa3 sites

  • Division of Neurology, Groote Schuur Hospital

    E 8-74, Groote Schuur Hospital, Observatory Cape Town, 7925

  • Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place

    Sandton, 2196

  • Umhlanga Hospital

    Umhlanga, KwaZulu-Natal, 4319

Other trials in South Africa

Sweden3 sites

  • Karolinska University Hospital Huddinge

    Department of Neurology R54, Stockholm, 14186

  • MS Centrum

    Forskningsenhet, SU/Östra CKÖ Plan 0, Gothenburg, 41345

  • Karolinska University Hospital, Department of Medicine

    Neuroimmunology Unit, CMM L8:04, Stockholm, 171 76

Other trials in Sweden

Switzerland3 sites

  • UniversitätsSpital Zürich, Neurologische Klinik

    Frauenklinikstr. 26, Zurich, 8091

  • Kantonsspital Basel, Policlinic

    Neurology-Neurosurgical, Petersgraben 4, Basel, 4031

  • Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie

    Rue Du Bugnon, Lausanne, 1011

Other trials in Switzerland

France1 site

  • CHU La Timone

    Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5, 13385

Other trials in France

Lithuania1 site

  • Kaunas University Hospital Department of Neurology

    Eiveniu 2, Kaunas, LY-50009

Other trials in Lithuania

About this study

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

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)

Being tested
Fingolimod 1.25 mg, Fingolimod 0.5 mg, Placebo
Keywords
Multiple Sclerosis, FTY720, Fingolimod
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fingolimod 1.25 mgDrug

    Patients self-administered fingolimod 1.25 mg capsules orally once daily.

  • Fingolimod 0.5 mgDrug

    Patients self-administered fingolimod 0.5 mg capsules orally once daily.

  • PlaceboDrug

    Patients self-administered a fingolimod placebo capsule orally once daily.

Study groups in NCT00289978
Study groupRoleWhat they receive
Fingolimod 1.25 mgExperimentalNot described
Receives: Drug: Fingolimod 1.25 mg
Fingolimod 0.5 mgExperimentalNot described
Receives: Drug: Fingolimod 0.5 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to end of study (Month 24)

Secondary outcomes (2)

  1. Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)

    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.

    Measured: Baseline to end of study (Month 24)

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

    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.

    Measured: Baseline to end of study (Month 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289978
Sponsor's protocol ID
CFTY720D2301
Acronym
FREEDOMS
Status last verified
Apr 2012
First submitted
9 Feb 2006
Last updated
11 Apr 2012

Publications

  • 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.

    PubMed 35698787

  • Fox 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.

    PubMed 27733070

  • Derfuss 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.

    PubMed 26121423

  • Kremenchutzky 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.

    PubMed 25876471

  • Chinea 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.

    PubMed 25245812

  • Zarbin 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.

    PubMed 23531349

  • 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.

    PubMed 22751847

  • 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.

    PubMed 22494956

  • 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.

    PubMed 20089952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fingolimod 1.25 mg and Fingolimod 0.5 mg in people with Relapsing-remitting Multiple Sclerosis, run by Novartis at 115 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in Germany, Turkey (Türkiye), Czechia, Poland, Belgium and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Annualized Aggregate Relapse Rate (ARR) (time frame: Baseline to end of study (Month 24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289978, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.

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