An Extension Study of Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis - Full Text View

An Extension Study of Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

This study is enrolling participants by invitation only.

Sponsors and Collaborators:	Novartis Mitsubishi Tanabe Pharma Corporation
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00670449

Purpose

This study is the extension study of NCT00537082. This study is designed to evaluate the efficacy and safety of long-term administration of 0.5mg or 1.25mg of FTY720 to relapsing multiple sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: FTY720	Phase II

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

FTY 720 Fingolimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Extension of the 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:

To evaluate the long-term efficacy of FTY720 on MRI lesion parameters at 3 and 6 month intervals.

Secondary Outcome Measures:

To evaluate the long-term efficacy of FTY720 on proportion of patients free of relapse at 3 and 6 month intervals.
To evaluate the long-term safety and tolerability of two doses of FTY720 at 3 and 6 month intervals.

Estimated Enrollment:	165
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2012

Arms	Assigned Interventions
1	Drug: FTY720
2	Drug: FTY720

Eligibility

Ages Eligible for Study:	18 Years to 61 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients who completed NCT00537082 study.
Females of childbearing potential have a negative pregnancy test in NCT00537082 study.

Exclusion Criteria:

Patients who permanently discontinued NCT00537082 study.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670449

Locations


Japan
	Novartis Investigative Site
	Osaka, Japan

Sponsors and Collaborators

Novartis

Mitsubishi Tanabe Pharma Corporation

Investigators


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

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D1201E1
First Received:	April 28, 2008
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00670449
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

FTY720

multiple sclerosis

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 10, 2008