Long Term Efficacy and Safety of FTY720 in Patients With Relapsing-remitting Multiple Sclerosis

This study has been completed.

First Received on April 17, 2008. Last Updated on November 16, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00662649

Purpose

This extension study is designed to evaluate the long-term safety, tolerability and efficacy of FTY720 in patients with multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod (FTY720)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of FTY720 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Fingolimod FTY 720

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

All safety analyses will be based mainly on the frequency of adverse events and on the incidence of clinically notable laboratory abnormalities.

Enrollment:	920
Study Start Date:	February 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FTY720 0.5mg FTY720 0.5mg/daily	Drug: Fingolimod (FTY720) Other Name: FTY720
Experimental: FTY720 1.25mg FTY720 1.25mg/day	Drug: Fingolimod (FTY720) Other Name: FTY720

Eligibility

Ages Eligible for Study:	20 Years to 58 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients should complete the 24 month core study

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662649

Show 105 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00662649 History of Changes
Other Study ID Numbers:	CFTY720D2301E1
Study First Received:	April 17, 2008
Last Updated:	November 16, 2011
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Novartis:

Multiple sclerosis.
Relapse-remitting
Fingolimod

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 February 09, 2012