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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: May 19, 2010
Last updated: February 21, 2017
Last verified: February 2017

May 19, 2010
February 21, 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 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
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
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 Identifier (NCT Number) in Medline.
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)
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
2010-019029-32 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2017

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