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

Sponsored by:	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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: FTY 720 Fingolimod

U.S. FDA Resources

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.

Further study details as provided by Novartis:

Primary Outcome Measures:

Annualized relapse rate in patients with RRMS treated for up to 24 months

Secondary Outcome Measures:

Proportion of relapse-free patients treated for up to 24 months
Safety and tolerability of fingolimod in patients treated for up to 24 months
Burden of disease and inflammatory activity as measured by MRI lesion parameters in patients treated for up to 24 months

Estimated Enrollment:	1080
Study Start Date:	June 2006
Estimated Study Completion Date:	September 2010

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

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

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Show 120 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

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

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2309
Study First Received:	July 19, 2006
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00355134
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

fingolimod
FTY720
relapsing-remitting multiple sclerosis
MS
RRMS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Fingolimod
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 14, 2009