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Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01127750
First Posted: May 21, 2010
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
May 19, 2010
May 21, 2010
February 23, 2017
May 2010
October 2011   (Final data collection date for primary outcome measure)
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01127750 on ClinicalTrials.gov Archive Site
  • Incidence of macular edema [ Time Frame: 4 months ]
  • Incidence of bradyarrhythmic electrocardiograms (ECGs) [ Time Frame: 4 months ]
  • Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
 
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
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
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
Drug: FTY720
Experimental: FTY720
Intervention: Drug: FTY720
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2417
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years of age, must have relapsing MS

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
 
NCT01127750
CFTY720D2316
2010-019029-32 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP