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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01127750
Registration number
NCT01127750
Ethics application status
Date submitted
19/05/2010
Date registered
21/05/2010
Date last updated
23/02/2017
Titles & IDs
Public title
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
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Scientific title
A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis
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Secondary ID [1]
0
0
2010-019029-32
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Secondary ID [2]
0
0
CFTY720D2316
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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:
Relapsing 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
Experimental: FTY720 -
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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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Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
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Assessment method [1]
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0
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Timepoint [1]
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0
4 months
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Secondary outcome [1]
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0
Incidence of macular edema
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Assessment method [1]
0
0
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Timepoint [1]
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4 months
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Secondary outcome [2]
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Incidence of bradyarrhythmic electrocardiograms (ECGs)
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Assessment method [2]
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0
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Timepoint [2]
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4 months
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Secondary outcome [3]
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Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
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Assessment method [3]
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0
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Timepoint [3]
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4 months
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Eligibility
Key inclusion criteria
* 18-65 years of age, must have relapsing MS
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Minimum age
18
Years
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Maximum age
65
Years
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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 a type of MS that is not relapsing
* Patients with history of chronic immune disease
* Patients with a history of certain cancers
* Diabetic patients with certain eye disorders
* Patients who are on certain immunosuppressive medications or heart medications
* Patients with certain heart conditions
* Patients with certain lung conditions
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
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/05/2010
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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
1/10/2011
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Sample size
Target
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Accrual to date
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Final
2417
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Box Hill
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Recruitment hospital [2]
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Novartis Investigative Site - Heidelberg
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Recruitment hospital [3]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [4]
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Novartis Investigative Site - Liverpool
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Recruitment hospital [5]
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Novartis Investigative Site - Woodville South
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment outside Australia
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Austria
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Linz
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Name
Novartis
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Summary
Brief summary
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
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Trial website
https://clinicaltrials.gov/study/NCT01127750
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Trial related presentations / publications
Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Journal
Gold R, Comi G, Palace J, Siever A, Gottschalk R, ...
[
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Results not provided in
https://clinicaltrials.gov/study/NCT01127750
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