Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Novartis Mitsubishi Tanabe Pharma Corporation |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00670449 |
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 |
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 |
Estimated Enrollment: | 165 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2012 |
Arms | Assigned Interventions |
---|---|
1 | Drug: FTY720 |
2 | Drug: FTY720 |
Ages Eligible for Study: | 18 Years to 61 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CFTY720D1201E1 |
Study First Received: | April 28, 2008 |
Last Updated: | April 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00670449 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
FTY720 multiple sclerosis MS |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Fingolimod |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Immunologic Factors Immune System Diseases Physiological Effects of Drugs |
Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions |