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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
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Condition Intervention Phase
Relapsing Multiple Sclerosis Drug: FTY720 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2417
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTY720 Drug: FTY720


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01127750

  Show 290 Study Locations
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT01127750     History of Changes
Other Study ID Numbers: CFTY720D2316
2010-019029-32 ( EudraCT Number )
Study First Received: May 19, 2010
Last Updated: February 21, 2017

Keywords provided by Novartis:
Relapsing multiple sclerosis
health outcomes

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017