Status:
COMPLETED
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).
Detailed Description
This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consis...
Eligibility Criteria
Inclusion
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
- Patients with a relapsing-remitting disease course
- Patients with expanded disability status scale (EDSS) score of 0-5.5
Exclusion
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
- For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
1083 Patients enrolled
Trial Details
Trial ID
NCT00355134
Start Date
June 1 2006
End Date
August 1 2011
Last Update
August 7 2012
Active Locations (112)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
2
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
3
University of South Alabama - Dept of Neurology
Mobile, Alabama, United States, 36693
4
Barrow Neurology Clinic
Phoenix, Arizona, United States, 85013