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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00670449
First received: April 28, 2008
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

Secondary Outcome Measures:
  • To evaluate the long-term efficacy of FTY720 on proportion of patients free of relapse at 3 and 6 month intervals. [ Time Frame: Month 3 and month 6 ] [ Designated as safety issue: No ]
  • To evaluate the long-term safety and tolerability of two doses of FTY720 at 3 and 6 month intervals. [ Time Frame: month 3 and month 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 165
Study Start Date: April 2008
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: FTY720
Other Name: Fingolimod
2 Drug: FTY720
Other Name: Fingolimod

  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
Kanagawa, Japan, 259-1193
Novartis Investigative Site
Kyoto, Japan, 604-8453
Novartis Investigative Site
Kyoto, Japan, 616-8255
Novartis Investigative Site
Morioka, Japan, 020-8505
Novartis Investigative Site
Niigata, Japan, 951-8520
Novartis Investigative Site
Osaka, Japan, 589-8511
Novartis Investigative Site
Osaka, Japan, 556-0016
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Sapporo, Japan, 060-8648
Novartis Investigative Site
Tochigi, Japan, 329-0498
Novartis Investigative Site
Tokyo, Japan, 145-0065
Novartis Investigative Site
Tokyo, Japan, 113-8519
Novartis Investigative Site
Tokyo, Japan, 162-8666
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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00670449     History of Changes
Other Study ID Numbers: CFTY720D1201E1
Study First Received: April 28, 2008
Last Updated: April 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
FTY720
multiple sclerosis
MS

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

ClinicalTrials.gov processed this record on May 16, 2013