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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01127750
First received: May 19, 2010
Last updated: January 18, 2012
Last verified: January 2012
History of Changes

May 19, 2010
January 18, 2012
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01127750 on ClinicalTrials.gov Archive Site
  • Incidence of macular edema [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Incidence of bradyarrhythmic electrocardiograms (ECGs) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
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: Open Label
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
Drug: FTY720
Experimental: FTY720
Intervention: Drug: FTY720
Not Provided

*   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.
Both
18 Years to 65 Years
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
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2012

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