Extension Study to Evaluate Safety, Tolerability and Effects on Efficacy Parameters of FTY720 in Patients With Relapsing Multiple Sclerosis. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00235430

Purpose

This study will evaluate the long-term safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod	Phase II

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: FTY 720 Fingolimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Extension Study to Evaluate Safety, Tolerability and Effects on Efficacy Parameters of FTY720 in Patients With Relapsing Multiple Sclerosis.

Further study details as provided by Novartis:

Enrollment:	250
Study Start Date:	January 2004
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
1: Experimental	Drug: Fingolimod 1.25 mg fingolimod given orally once daily

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with relapsing MS who completed the Month 6 visit of study CFTY720D2201.

Exclusion Criteria:

All patients who permanently discontinued study medication prior to the Month 6 visit of study CFTY720D2201.

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235430

Locations

Canada
Novartis Investigational site
Toronto, Canada
Novartis Investigational site
Montreal, Canada
Novartis Investigational site
Vancouver, Canada
Novartis Investigational site
Ottawa, Canada
Denmark
Novartis Investigational site
Copenhagen, Denmark
Finland
Novartis Investigational site
Helsinki, Finland
Novartis Investigational site
Turku, Finland
Novartis Investigational site
Tampere, Finland
France
Novartis Investigational site
Marseille, France
Novartis Investigational site
Lille, France
Germany
Novartis Investigational site
Wurzburg, Germany
Novartis Investigational site
Schwendi, Germany
Italy
Novartis Investigational site
Milano, Italy
Novartis Investigational site
Gallarate, Italy
Novartis Investigational site
Genova, Italy
Novartis Investigational site
Roma, Italy
Poland
Novartis Investigational site
Warszawa, Poland
Portugal
Novartis Investigational site
Lisboa, Portugal
Novartis Investigational site
Coimbra, Portugal
Spain
Novartis Investigational site
Barcelona, Spain
Novartis Investigational site
Malaga, Spain
Novartis Investigational site
Sevilla, Spain
Novartis Investigational site
Madrid, Spain
Novartis Investigational site
Valencia, Spain
Switzerland
Novartis Investigational site
Basel, Switzerland
Novartis Investigational site
Zurich, Switzerland
United Kingdom
Novartis Investigational site
Newcastle upon Tyne, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Publications of Results:

Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40.

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2201E1
Study First Received:	October 6, 2005
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00235430
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Novartis:

FTY720
Multiple Sclerosis
MS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Fingolimod

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009