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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
  Purpose

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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127750

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01127750     History of Changes
Other Study ID Numbers: CFTY720D2316, 2010-019029-32
Study First Received: May 19, 2010
Last Updated: January 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Relapsing multiple sclerosis
MS
safety
tolerability
health outcomes

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013