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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
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Belgium
State/province [2] 0 0
Brussels
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Sijsele
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Belgium
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St.Truiden
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Belgium
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Boemerangstraat 2, Overpelt
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Belgium
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Vanheylenstraat 16, Melsbroek
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Czech Republic
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Brno
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Czech Republic
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Olomouc
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Czech Republic
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Pardubice
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Czech Republic
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Plzen
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Czech Republic
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Prague 5
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Czech Republic
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Praha 2
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Czech Republic
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Praha
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Czech Republic
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Teplice
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Czech Republic
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Jiraskova 1389, Rychnov nad Kneznou
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Czech Republic
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Ostrava
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Finland
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Helsinki
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Finland
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Turku
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Finland
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Hämeenkatu 18, 6th fl., Tampere
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Finland
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Kiinanmyllynkatu 11- 14, Turku
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Finland
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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
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Berlin
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Germany
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Dusseldorf
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Germany
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Giessen
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Magdeburg
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Germany
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Munchen
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Germany
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Munster
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Germany
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Regensburg
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Germany
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Seesen/Harz
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Germany
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Stuttgart
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Germany
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Tubingen
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Germany
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Wurzburg
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Greece
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Athens
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Greece
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Mesogeion 154 Ave., Athens
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Greece
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Terma Zaimi, Melissia-Athens
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Greece
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Thessaloniki
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Israel
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Ashkelon
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Israel
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Haifa
Country [49] 0 0
Israel
State/province [49] 0 0
Safed
Country [50] 0 0
Israel
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Tel Hashomer, Ramat-Gan,
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Lithuania
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Eiveniu 2, Kaunas
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Netherlands
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Amsterdam
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Netherlands
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Nieuwegein
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Nyimegen
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Rotterdam
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Netherlands
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Tilburg
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Netherlands
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Walramstraat 23, BK Sittard
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Poland
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Bialystok
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Gdansk
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Katowice
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Warszawa
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Lodz
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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St-Petersburg
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Kollárova 2, Martin
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Slovakia
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Mickiewiczova 13, Bratislava
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Slovakia
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ul.V. Spanyola 43, Žilina
Country [73] 0 0
South Africa
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KZN
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South Africa
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E 8-74, Groote Schuur Hospital, Observatory Cape Town
Country [75] 0 0
South Africa
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Sandton
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Sweden
State/province [76] 0 0
Gothenburg
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Sweden
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Department Of Neurology R54, Stockholm
Country [78] 0 0
Sweden
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Neuroimmunology unit, CMM L8:04, Stockholm
Country [79] 0 0
Switzerland
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Basel
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Switzerland
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Lausanne
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Switzerland
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Frauenklinikstr. 26, Zurich
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Turkey
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Ankara
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Turkey
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Besevler Ankara
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Turkey
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Bornova Izmir
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Turkey
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Capa Istanbul
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Turkey
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Cerrahpasa Istanbul
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Turkey
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Gaziantep
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Turkey
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Görükle / Bursa
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Turkey
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Hospital Neurology Service, 35120 Gaziler Cad. Izmir
Country [90] 0 0
Turkey
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Inciralti, Izmir
Country [91] 0 0
Turkey
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Istanbul
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Turkey
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Noroloji ABD, Mersin
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Turkey
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Noroloji Klinigi, Göztepe Istanbul
Country [94] 0 0
United Kingdom
State/province [94] 0 0
London
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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United Kingdom
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00289978