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

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00537082
First received: September 26, 2007
Last updated: April 19, 2011
Last verified: April 2011
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only) [ Time Frame: up to Month 6 ] [ Designated as safety issue: No ]
    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).

  • Number of Patients Free of New or Newly Enlarged T2 Lesions [ Time Frame: up to Month 3 and up to Month 6 ] [ Designated as safety issue: No ]
    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.

  • Annualized Relapse Rate (ARR) at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 171
Study Start Date: September 2007
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Administered orally once daily for 6 months

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Novartis Investigative site
Sapporo-shi, Hokkaido, Japan
Novartis Investigative Site
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
Iwate, Japan, 020-8505
Novartis Investigative Site
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, 162-8666
Novartis Investigative Site
Tokyo, Japan, 145-0065
Novartis Investigative Site
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Novartis
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Novartis Pharmaceuticals, Japan +81 3 3797 8748
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, No
ClinicalTrials.gov Identifier: NCT00537082     History of Changes
Other Study ID Numbers: CFTY720D1201
Study First Received: September 26, 2007
Results First Received: February 21, 2011
Last Updated: April 19, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
FTY720,
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014