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

April 19, 2011 updated by: Novartis

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered orally once daily for 6 months
Experimental: FTY720 0.5 mg
FTY720
Drug: FTY720
Administered orally once daily for 6 months
Experimental: FTY720 1.25 mg
FTY720
Drug: FTY720
Administered orally once daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Time Frame: Month 3 and Month 6
Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.
Month 3 and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
Time Frame: up to Month 6
A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).
up to Month 6
Number of Patients Free of New or Newly Enlarged T2 Lesions
Time Frame: up to Month 3 and up to Month 6
The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.
up to Month 3 and up to Month 6
Annualized Relapse Rate (ARR) at 6 Months
Time Frame: 6 Months
Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2011

Last Update Submitted That Met QC Criteria

April 19, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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