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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00662649
Registration number
NCT00662649
Ethics application status
Date submitted
17/04/2008
Date registered
21/04/2008
Date last updated
12/07/2012
Titles & IDs
Public title
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
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Scientific title
An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 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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2007-004122-24
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Secondary ID [2]
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CFTY720D2301E1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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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 0.5 mg
Treatment: Drugs - Fingolimod 1.25 mg
Experimental: Fingolimod 1.25 mg - Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study.
Experimental: Fingolimod 0.5 mg - Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study.
Experimental: Placebo-fingolimod - Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study.
Experimental: Placebo-fingolimod 1.25 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study.
Experimental: Placebo-fingolimod 0.5 mg - Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.
Treatment: Drugs: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Treatment: Drugs: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules 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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Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
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Assessment method [1]
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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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Months 0 to end of study (maximum up to 60 months)
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Primary outcome [2]
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Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
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Assessment method [2]
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A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
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Timepoint [2]
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Core baseline to end of study (maximum up to 60 months)
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Primary outcome [3]
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Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
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Assessment method [3]
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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 [3]
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Months 0-24 (core study) and Months 24-48 (extension study)
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Primary outcome [4]
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Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
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Assessment method [4]
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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 [4]
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Months 0-24 (core study) and Months 24-48 (extension study)
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Secondary outcome [1]
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Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
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Assessment method [1]
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The number of new or newly enlarged T2 lesions was assessed with T2-weighted 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 [1]
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Months 0-24 (core study) and Months 24-48 (extension study)
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Secondary outcome [2]
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Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
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Assessment method [2]
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The number of new or newly enlarged T2 lesions was assessed with T2-weighted 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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Months 0-24 (core study) and Months 24-48 (extension study)
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Secondary outcome [3]
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Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
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Assessment method [3]
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Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
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Timepoint [3]
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Months 0-24 (core study) and Months 24-48 (extension study)
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Secondary outcome [4]
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Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
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Assessment method [4]
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Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
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Timepoint [4]
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Months 0 to end of study (maximum up to 60 months)
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Secondary outcome [5]
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Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
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Assessment method [5]
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Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.
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Timepoint [5]
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Core baseline to end of study (maximum up to 60 months)
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Eligibility
Key inclusion criteria
* Patients should complete the 24 month core study
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Minimum age
20
Years
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Maximum age
58
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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 may apply.
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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 administering the treatment/s
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
1/02/2008
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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
1/06/2011
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Sample size
Target
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Accrual to date
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Final
920
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Chatswood
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Recruitment hospital [2]
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Novartis Investigative Site - Fitzroy
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Recruitment hospital [3]
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Austin Health, Department of Neurology - Heidelberg
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Recruitment hospital [4]
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Novartis Investigative Site - North Gosford
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Recruitment hospital [5]
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Novartis Investigative Site - Woodville
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Recruitment postcode(s) [1]
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- Chatswood
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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- Heidelberg
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Recruitment postcode(s) [4]
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- North Gosford
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Recruitment postcode(s) [5]
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- Woodville
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Recruitment outside Australia
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Leuven
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Overpelt
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Belgium
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Sijsele - Damme
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Halifax
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Kingston
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Brno
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Bristol
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Nottingham
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
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Trial website
https://clinicaltrials.gov/study/NCT00662649
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00662649
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