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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00289978




Registration number
NCT00289978
Ethics application status
Date submitted
9/02/2006
Date registered
10/02/2006
Date last updated
11/04/2012

Titles & IDs
Public title
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
CFTY720D2301
Universal Trial Number (UTN)
Trial acronym
FREEDOMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod 1.25 mg
Treatment: Drugs - Fingolimod 0.5 mg
Treatment: Drugs - Placebo

Experimental: Fingolimod 1.25 mg -

Experimental: Fingolimod 0.5 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.

Treatment: Drugs: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.

Treatment: Drugs: Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated Annualized Aggregate Relapse Rate (ARR)
Timepoint [1] 0 0
Baseline to end of study (Month 24)
Secondary outcome [1] 0 0
Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
Timepoint [1] 0 0
Baseline to end of study (Month 24)
Secondary outcome [2] 0 0
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
Timepoint [2] 0 0
Baseline to end of study (Month 24)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2009
Sample size
Target
Accrual to date
Final
1272
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
North Gosford Private Hospital - Burrabil Avenue, Suite 17, Gosford
Recruitment hospital [3] 0 0
Strategic Health Evaluators - Chatswood
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences - Fitzroy
Recruitment hospital [5] 0 0
Austin Health, Department of Neurology - Heidelberg
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
NSW 2250 - Burrabil Avenue, Suite 17, Gosford
Recruitment postcode(s) [3] 0 0
2067 - Chatswood
Recruitment postcode(s) [4] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Sijsele
Country [6] 0 0
Belgium
State/province [6] 0 0
St.Truiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Boemerangstraat 2, Overpelt
Country [8] 0 0
Belgium
State/province [8] 0 0
Vanheylenstraat 16, Melsbroek
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Saskatchewan
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Olomouc
Country [16] 0 0
Czech Republic
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Pardubice
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Czech Republic
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Plzen
Country [18] 0 0
Czech Republic
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Prague 5
Country [19] 0 0
Czech Republic
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Praha 2
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Teplice
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Jiraskova 1389, Rychnov nad Kneznou
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Ostrava
Country [24] 0 0
Finland
State/province [24] 0 0
Helsinki
Country [25] 0 0
Finland
State/province [25] 0 0
Turku
Country [26] 0 0
Finland
State/province [26] 0 0
Hämeenkatu 18, 6th fl., Tampere
Country [27] 0 0
Finland
State/province [27] 0 0
Kiinanmyllynkatu 11- 14, Turku
Country [28] 0 0
Finland
State/province [28] 0 0
Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää
Country [29] 0 0
France
State/province [29] 0 0
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Dusseldorf
Country [32] 0 0
Germany
State/province [32] 0 0
Giessen
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Germany
State/province [33] 0 0
Hamburg
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Germany
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Leipzig
Country [35] 0 0
Germany
State/province [35] 0 0
Magdeburg
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Germany
State/province [36] 0 0
Munchen
Country [37] 0 0
Germany
State/province [37] 0 0
Munster
Country [38] 0 0
Germany
State/province [38] 0 0
Regensburg
Country [39] 0 0
Germany
State/province [39] 0 0
Seesen/Harz
Country [40] 0 0
Germany
State/province [40] 0 0
Stuttgart
Country [41] 0 0
Germany
State/province [41] 0 0
Tubingen
Country [42] 0 0
Germany
State/province [42] 0 0
Wurzburg
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Mesogeion 154 Ave., Athens
Country [45] 0 0
Greece
State/province [45] 0 0
Terma Zaimi, Melissia-Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Israel
State/province [47] 0 0
Ashkelon
Country [48] 0 0
Israel
State/province [48] 0 0
Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Safed
Country [50] 0 0
Israel
State/province [50] 0 0
Tel Hashomer, Ramat-Gan,
Country [51] 0 0
Lithuania
State/province [51] 0 0
Eiveniu 2, Kaunas
Country [52] 0 0
Netherlands
State/province [52] 0 0
Amsterdam
Country [53] 0 0
Netherlands
State/province [53] 0 0
Nieuwegein
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Netherlands
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Nyimegen
Country [55] 0 0
Netherlands
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Rotterdam
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Netherlands
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Tilburg
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Netherlands
State/province [57] 0 0
Walramstraat 23, BK Sittard
Country [58] 0 0
Poland
State/province [58] 0 0
Bialystok
Country [59] 0 0
Poland
State/province [59] 0 0
Gdansk
Country [60] 0 0
Poland
State/province [60] 0 0
Katowice
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Poland
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Poznan
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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Lodz
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Russian Federation
State/province [65] 0 0
Kazan
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St-Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
Country [69] 0 0
Slovakia
State/province [69] 0 0
Bratislava
Country [70] 0 0
Slovakia
State/province [70] 0 0
Kollárova 2, Martin
Country [71] 0 0
Slovakia
State/province [71] 0 0
Mickiewiczova 13, Bratislava
Country [72] 0 0
Slovakia
State/province [72] 0 0
ul.V. Spanyola 43, Žilina
Country [73] 0 0
South Africa
State/province [73] 0 0
KZN
Country [74] 0 0
South Africa
State/province [74] 0 0
E 8-74, Groote Schuur Hospital, Observatory Cape Town
Country [75] 0 0
South Africa
State/province [75] 0 0
Sandton
Country [76] 0 0
Sweden
State/province [76] 0 0
Gothenburg
Country [77] 0 0
Sweden
State/province [77] 0 0
Department Of Neurology R54, Stockholm
Country [78] 0 0
Sweden
State/province [78] 0 0
Neuroimmunology unit, CMM L8:04, Stockholm
Country [79] 0 0
Switzerland
State/province [79] 0 0
Basel
Country [80] 0 0
Switzerland
State/province [80] 0 0
Lausanne
Country [81] 0 0
Switzerland
State/province [81] 0 0
Frauenklinikstr. 26, Zurich
Country [82] 0 0
Turkey
State/province [82] 0 0
Ankara
Country [83] 0 0
Turkey
State/province [83] 0 0
Besevler Ankara
Country [84] 0 0
Turkey
State/province [84] 0 0
Bornova Izmir
Country [85] 0 0
Turkey
State/province [85] 0 0
Capa Istanbul
Country [86] 0 0
Turkey
State/province [86] 0 0
Cerrahpasa Istanbul
Country [87] 0 0
Turkey
State/province [87] 0 0
Gaziantep
Country [88] 0 0
Turkey
State/province [88] 0 0
Görükle / Bursa
Country [89] 0 0
Turkey
State/province [89] 0 0
Hospital Neurology Service, 35120 Gaziler Cad. Izmir
Country [90] 0 0
Turkey
State/province [90] 0 0
Inciralti, Izmir
Country [91] 0 0
Turkey
State/province [91] 0 0
Istanbul
Country [92] 0 0
Turkey
State/province [92] 0 0
Noroloji ABD, Mersin
Country [93] 0 0
Turkey
State/province [93] 0 0
Noroloji Klinigi, Göztepe Istanbul
Country [94] 0 0
United Kingdom
State/province [94] 0 0
London
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Nottingham
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Sheffield
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Backshaw Road, London
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Beckspool Road, Bristol
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Queen Victoria Road, Newcastle-upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00289978
Trial related presentations / 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.
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.
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.
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.
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.
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.
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.
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. Erratum In: Lancet Neurol. 2012 Aug;11(8):658.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00289978