Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00355134

Purpose

This study will assess safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fingolimod Drug: Fingolimod matching placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) 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:

Annualized relapse rate in patients with RRMS treated for up to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of relapse-free patients treated for up to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Safety and tolerability of fingolimod in patients treated for up to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Burden of disease and inflammatory activity as measured by MRI lesion parameters in patients treated for up to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1080
Study Start Date:	June 2006
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose 0.5 mg	Drug: Fingolimod
2: Experimental Dose 1.25 mg	Drug: Fingolimod
3: Placebo Comparator	Drug: Fingolimod matching placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

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: NCT00355134

Show 107 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Additional Information:

Fingolimod clinical trials information website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2309
Study First Received:	July 19, 2006
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00355134 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

fingolimod
FTY720
relapsing-remitting multiple sclerosis
MS
RRMS

Additional relevant MeSH terms:

Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Fingolimod
Physiological Effects of Drugs
Nervous System Diseases

Sclerosis
Immunosuppressive Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 20, 2009