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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

August 21, 2008

Start Date ^†

September 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537082 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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)

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Multiple Sclerosis

Intervention ^†

Drug: FTY720

Study Arms / Comparison Groups

Experimental: FTY720

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

165

Estimated Completion Date

October 2009

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis Pharmaceuticals, Japan

+81 3 3797 8748

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537082

Responsible Party

External Affairs, No

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Mitsubishi Tanabe Pharma Corporation

Investigators ^†

Principal Investigator:

Novartis Pharmaceuticals, Japan

+81 3 3797 8748

Information Provided By

Novartis

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.