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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
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
Secondary ID [1] 0 0
2010-019029-32
Secondary ID [2] 0 0
CFTY720D2316
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: FTY720 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
Timepoint [1] 0 0
4 months
Secondary outcome [1] 0 0
Incidence of macular edema
Timepoint [1] 0 0
4 months
Secondary outcome [2] 0 0
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Timepoint [2] 0 0
4 months
Secondary outcome [3] 0 0
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
Timepoint [3] 0 0
4 months

Eligibility
Key inclusion criteria
* 18-65 years of age, must have relapsing MS
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
2417
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woodville South
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
Austria
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Linz
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Austria
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Vienna
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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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Belgium
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Melsbroek
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Overpelt
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Sijsele
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Tinlot
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Wilrijk
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Montreal
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Truro

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

TypeCitations or Other Details
Journal Gold R, Comi G, Palace J, Siever A, Gottschalk R, ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01127750