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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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CFTY720D2301
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Universal Trial Number (UTN)
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Trial acronym
FREEDOMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-remitting Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Estimated Annualized Aggregate Relapse Rate (ARR)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to end of study (Month 24)
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Secondary outcome [1]
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Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to end of study (Month 24)
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Secondary outcome [2]
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Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to end of study (Month 24)
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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
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Minimum age
18
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2009
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Sample size
Target
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Accrual to date
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Final
1272
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [2]
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North Gosford Private Hospital - Burrabil Avenue, Suite 17, Gosford
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Recruitment hospital [3]
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Strategic Health Evaluators - Chatswood
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Recruitment hospital [4]
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St Vincent's Hospital Melbourne, Department of Clinical Neurosciences - Fitzroy
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Recruitment hospital [5]
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Austin Health, Department of Neurology - Heidelberg
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Recruitment postcode(s) [1]
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5011 - Woodville South
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Recruitment postcode(s) [2]
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NSW 2250 - Burrabil Avenue, Suite 17, Gosford
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Recruitment postcode(s) [3]
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2067 - Chatswood
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Recruitment postcode(s) [4]
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3065 VIC - Fitzroy
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment outside Australia
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Brugge
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Boemerangstraat 2, Overpelt
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Vanheylenstraat 16, Melsbroek
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Teplice
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Jiraskova 1389, Rychnov nad Kneznou
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Hämeenkatu 18, 6th fl., Tampere
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Kiinanmyllynkatu 11- 14, Turku
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Neurologian poliklinikka, Sairaalankatu 1, Hyvinkää
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Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5
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Berlin
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Mesogeion 154 Ave., Athens
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Terma Zaimi, Melissia-Athens
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Tel Hashomer, Ramat-Gan,
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Eiveniu 2, Kaunas
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Kollárova 2, Martin
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Mickiewiczova 13, Bratislava
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ul.V. Spanyola 43, Žilina
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E 8-74, Groote Schuur Hospital, Observatory Cape Town
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Sandton
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Gothenburg
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Department Of Neurology R54, Stockholm
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Neuroimmunology unit, CMM L8:04, Stockholm
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Basel
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Frauenklinikstr. 26, Zurich
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Hospital Neurology Service, 35120 Gaziler Cad. Izmir
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Inciralti, Izmir
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Istanbul
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Noroloji ABD, Mersin
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Noroloji Klinigi, Göztepe Istanbul
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London
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Nottingham
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Sheffield
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Backshaw Road, London
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Beckspool Road, Bristol
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United Kingdom
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Queen Victoria Road, Newcastle-upon-Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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Ethics approval
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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)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00289978
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00289978
Download to PDF