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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— FREEDOMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289978
• Other study ID #: CFTY720D2301
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: April 9, 2012
• Start date: January 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1272
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
• Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
• Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.

Locations

Country	Name	City	State
Australia	North Gosford Private Hospital	Burrabil Avenue, Suite 17, Gosford
Australia	Strategic Health Evaluators	Chatswood
Australia	St Vincent's Hospital Melbourne, Department of Clinical Neurosciences	Fitzroy
Australia	Austin Health, Department of Neurology	Heidelberg
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Belgium	MS Klinik	Boemerangstraat 2, Overpelt
Belgium	CHU Charleroi, Hôpital Civil	Boulevard Paul Janson 92	Charleroi
Belgium	University Hospital Gasthuisberg	Department Neurology, Herestraat 49	Leuven
Belgium	AZ Alma	Department of Neurology & Rehab-Umit, Gentsesteenweg 132	Sijsele
Belgium	Erasme Hospital	Route de Lennik 808	Brussels
Belgium	Algemeen Ziekenhuis St. Jan, Department of Neurology	Ruddershove 10	Brugge
Belgium	Regionaal Ziekenhuis	St.Trudo, Diestersteenweg 100,	St.Truiden
Belgium	National Multiple Sclerose Centrum v.z.w	Vanheylenstraat 16, Melsbroek
Canada	Kingston General Hospital, MS Clinic	Connell 7, 76 Stuart Street, Kingston	Ontario
Canada	DMSRU - Capital Health	Halifax	Nova Scotia
Canada	University of British Columbia	ME498 2211 Wesbrook Mall, Vancouver	British Columbia
Canada	Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie	Montreal	Quebec
Canada	Nepean Medical Center	Ottawa	Ontario
Canada	University of Saskatchewan	Regina	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Clinical Trials Office,	Trillium Health Center, 00 Queesway West, Mississauga	Ontario
Czech Republic	Faculty Hospital	Department of Neurology, Alej Svobody 80	Plzen
Czech Republic	Faculty Hospital	Department of Neurology, I.P. Paulova 6	Olomouc
Czech Republic	Hospital of Pardubice	Department of Neurology, Kyjevska 44	Pardubice
Czech Republic	Faculty Hospital Motol, MS Center	Department of Neurology, V Uvalu 84	Prague 5
Czech Republic	Military Hospital of Brno	Department of Neurology, Zabrdovicka 3	Brno
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	Neurologicka klinika, Fakultni nemocnice	Kralovske Vinohrady, Srobarova 50	Praha
Czech Republic	Vseobecna fakultni nemocnice	MS Centrum, Neurologicka klinika, Karlovo namesti 32	Praha 2
Czech Republic	MS Centrum	Neurology Department of Hospital Teplice, Duchcovska 53	Teplice
Czech Republic	Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department	Ostrava
Finland	Finnish Special Neurology Center Ltd.	Brahenkatu 11 D,	Turku
Finland	Suomen Terveystalo/ Päänsärkykeskus, Tampere	Hämeenkatu 18, 6th fl., Tampere
Finland	Turku University Hospital, Neurology Department 799	Kiinanmyllynkatu 11- 14, Turku
Finland	Helsinki Headache Center Postitalon Lääkäriasema	Mannnerheiminaukio 1 B 2 Floor	Helsinki
Finland	Hyvinkään sairaala	Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää
France	CHU La Timone	Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5
Germany	Investigational Site	Berlin
Germany	Investigational Site	Berlin
Germany	Investigational Site	Dusseldorf
Germany	Investigational Site	Giessen
Germany	Investigational Site	Hamburg
Germany	Investigational Site	Hamburg
Germany	Investigational Site	Leipzig
Germany	Investigational Site	Magdeburg
Germany	Investigational Site	Munchen
Germany	Investigational Site	Munchen
Germany	Investigational Site	Munster
Germany	Investigational Site	Regensburg
Germany	Investigational Site	Seesen/Harz
Germany	Investigational Site	Stuttgart
Germany	Investigational Site	Tubingen
Germany	Investigational Site	Wurzburg
Greece	Athens Naval Hospital, Neurology Department	Athens
Greece	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
Israel	Barzilai Medical Center	Ashkelon
Israel	Carmel Medical Center	Haifa
Israel	Sieff Medical Center	Safed
Israel	Sheba - Medical Center	Tel Hashomer, Ramat-Gan,
Lithuania	Kaunas University Hospital Department of Neurology	Eiveniu 2, Kaunas
Netherlands	Academisch Ziekenhuis VU	De Boelelaan 1118	Amsterdam
Netherlands	Erasmus MC	Dr. Molewaterplein 40	Rotterdam
Netherlands	Multiple Clerosis Center Nijmegen	Heiweg 97	Nyimegen
Netherlands	Sint Elisabeth Ziekenhuis	Hilvarenbeekse Weg 60	Tilburg
Netherlands	St. Antonius Ziekenhuis	Postbus 2500	Nieuwegein
Netherlands	Maaslandziekenhuis Sittard	Walramstraat 23, BK Sittard
Poland	Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,	Department of Neurology, ul. Przybyszewskiego 49	Poznan
Poland	CSK MSWiA Hospital	Department of Neurology, Woloska 137	Warsaw
Poland	Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii	II Klinika Neurologii, ul. Sobieskiego 1/9	Warsaw
Poland	Samodzielny Publiczny Szpital Kliniczny	Klinika Neurologii, Ul. Marii Sklodowskiej-Curie 24 A	Bialystok
Poland	Medical University of Lodz	Lodz
Poland	Oddzial Neurologiczny i Leczenia Udarow	Mozgu, Nowe Ogrody 1/6	Gdansk
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	Katedra i Klinika Neurologii Slaskiej Akademii Medycznej	ul. Medykow 14	Katowice
Poland	Niezalezny Zespol Opieki Zdrowotnej Kendron	Ul. Swietego Mikolaja 1/8	Bialystok
Russian Federation	Interregional Clinical Diagnistic Center, Neurology Department	Kazan
Russian Federation	Central Clinical Hospital of Medical Center of Administration of President of Russian Federation	Moscow
Russian Federation	Moscow Regional Research Clinical Institue	Moscow
Russian Federation	GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department	St-Petersburg
Russian Federation	Military Medical Academy, Neurology Department	St. Petersburg
Slovakia	Neurologická klinika, Martinská fakultná nemocnica	Kollárova 2, Martin
Slovakia	II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre	Limbová 5	Bratislava
Slovakia	I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto	Mickiewiczova 13, Bratislava
Slovakia	Neurologické oddelenie, Nemocnica s poliklinikou Žilina	ul.V. Spanyola 43, Žilina
South Africa	Division of Neurology, Groote Schuur Hospital	E 8-74, Groote Schuur Hospital, Observatory Cape Town
South Africa	Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place	Sandton
South Africa	Umhlanga Hospital	Umhlanga	KZN
Sweden	Karolinska University Hospital Huddinge	Department Of Neurology R54, Stockholm
Sweden	MS Centrum	Forskningsenhet, SU/Östra CKÖ plan 0	Gothenburg
Sweden	Karolinska University Hospital, Department of Medicine	Neuroimmunology unit, CMM L8:04, Stockholm
Switzerland	UniversitätsSpital Zürich, Neurologische Klinik	Frauenklinikstr. 26, Zurich
Switzerland	Kantonsspital Basel, Policlinic	Neurology-Neurosurgical, Petersgraben 4	Basel
Switzerland	Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie	Rue du Bugnon	Lausanne
Turkey	Istanbul University, Istanbul Faculty of Medicine	Departement of Neurology	Capa Istanbul
Turkey	Hacettepe Universiti Hospitals	Department of Neurology	Ankara
Turkey	Istanbul University, Cerrahpasa School of Medicine	Department of Neurology	Cerrahpasa Istanbul
Turkey	Tepecik Training and Research	Hospital Neurology Service, 35120 Gaziler Cad. Izmir
Turkey	Dokuz University Medical Faculty, Neurology Department	Inciralti, Izmir
Turkey	Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi	Istanbul
Turkey	EGE University	Medical Faculty Hospital Neurolgy Department	Bornova Izmir
Turkey	Gazi University	Medical Faculty Neurology Department	Besevler Ankara
Turkey	Gaziantep University School of Medicine	Neurology Department	Gaziantep
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi	Noroloji ABD, Mersin
Turkey	T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi	Noroloji Klinigi, Göztepe Istanbul
Turkey	Uludag University Faculty of Medche	Tip Fakultesi, Noroloji ABD	Görükle / Bursa
United Kingdom	St. George's Hospital, Neurology Dept. Atkinson Morley Wing	Backshaw Road, London
United Kingdom	Frenchay Hospital, Department of Neurology	Beckspool Road, Bristol
United Kingdom	Queens Medical Centre	Division of Clinical Neurology Medical School	Nottingham
United Kingdom	Royal Hallamshire Hospital	Glossop Road	Sheffield
United Kingdom	King's College Hospital, Trials office Academie Neuroscience Center	P041 Institute of Psychiatry, Denmark Hill	London
United Kingdom	Royal Victoria Infirmary	Queen Victoria Road, Newcastle-upon-Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Israel,  Lithuania,  Netherlands,  Poland,  Russian Federation,  Slovakia,  South Africa,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	Baseline to end of study (Month 24)	No
Secondary	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.	Baseline to end of study (Month 24)	No

External Links

•   Fingolimod clinical trials information website