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

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

This study is currently recruiting participants.
Verified by Novartis, August 2008

Sponsors and Collaborators:	Novartis Mitsubishi Tanabe Pharma Corporation
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00537082

Purpose

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)

Condition	Intervention	Phase
Multiple Sclerosis	Drug: FTY720	Phase II

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 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate the effect of FTY720 on monthly magnetic resonance imaging (MRI) lesion parameters.

Secondary Outcome Measures:

Evaluate the effect of FTY720 on proportion of patients free of relapse at Month 6. Evaluate the safety and tolerability of two doses of FTY720 at Month 6.

Estimated Enrollment:	165
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: Experimental FTY720	Drug: FTY720
2: Experimental FTY720	Drug: FTY720
3: Placebo Comparator	Drug: FTY720

Eligibility

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

Criteria

Inclusion Criteria:

Male and female patients aged 18-60
Patients with a diagnosis of multiple sclerosis

Exclusion Criteria:

Patients with a history or presence of chronic disease of the immune system other than MS
Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537082

Contacts


Contact: Novartis Pharmaceuticals, Japan	+81 3 3797 8748

Locations


Japan, Hokkaido
	Novartis Investigative site	Recruiting
	Sapporo-shi, Hokkaido, Japan
	Contact +81 3 3797 8748

Sponsors and Collaborators

Novartis

Mitsubishi Tanabe Pharma Corporation

Investigators


Principal Investigator:	Novartis Pharmaceuticals, Japan	+81 3 3797 8748

More Information

Responsible Party:	No ( External Affairs )
Study ID Numbers:	CFTY720D1201
First Received:	September 26, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00537082
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

FTY720,

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

FTY 720

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 October 24, 2008