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

This study is ongoing, but not recruiting participants.

First Received: September 26, 2007 Last Updated: August 11, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: FTY 720

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Evaluate the effect of FTY720 on monthly magnetic resonance imaging (MRI) lesion parameters. [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: No ]

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. [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	September 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

Locations

Japan
Novartis Investigative Site
Kyoto, Japan, 604-8453
Novartis Investigative Site
Kyoto, Japan, 616-8255
Novartis
Iwate, Japan, 020-8505
Novartis Investigative Site
Tokyo, Japan, 145-0065
Novartis Investigative Site
Kanagawa, Japan, 259-1193
Novartis Investigative Site
Tochigi, Japan, 329-0498
Novartis Investigative Site
Gunma, Japan, 371-8511
Novartis Investigative Site
Ibaraki, Japan, 305-8576
Novartis Investigative Site
Tokyo, Japan, 162-8666
Novartis Investigative Site
Niigata, Japan, 951-8520
Novartis Investigative Site
Osaka, Japan, 589-8511
Novartis Investigative Site
Hyogo, Japan, 650-0017
Novartis Investigative Site
Ehime, Japan, 791-0295
Novartis Investigative Site
Fukuoka, Japan, 807-8555
Novartis Investigative Site
Osaka, Japan, 556-0016
Novartis Investigative Site
Wakayama, Japan, 641-8510
Novartis Investigative Site
Chiba, Japan, 276-8524
Japan, Hokkaido
Novartis Investigative site
Sapporo-shi, Hokkaido, Japan

Sponsors and Collaborators

Novartis

Mitsubishi Tanabe Pharma Corporation

Investigators

Principal Investigator:

Novartis Pharmaceuticals, Japan

+81 3 3797 8748

More Information

No publications provided

Responsible Party:	No ( External Affairs )
Study ID Numbers:	CFTY720D1201
Study First Received:	September 26, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00537082 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

FTY720,
MS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Fingolimod

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Immunosuppressive Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Fingolimod
Nervous System Diseases
Physiological Effects of Drugs

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 September 11, 2009