Status:
COMPLETED
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
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 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclero...
Eligibility Criteria
Inclusion
- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
- 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
- Patients who cannot tolerate treatment with an interferon
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1292 Patients enrolled
Trial Details
Trial ID
NCT00340834
Start Date
May 1 2006
End Date
July 1 2011
Last Update
September 21 2017
Active Locations (170)
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1
North Central Neurology Associates, PC, 1809 Kress Street
Cullman, Alabama, United States, 35058
2
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
3
The Neurology Center, 3907 Waring Road, Suite 3
Oceanside, California, United States, 92056
4
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
Danbury, Connecticut, United States, 06810