Status:
COMPLETED
A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Forms of Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Scler...
Eligibility Criteria
Inclusion
- Relapsing forms of MS
- Expanded Disability Status Scale (EDSS) 0-5.5
- Continuous treatment with MS DMT for a minimum of 6 months
- Fingolimod naive
Exclusion
- Immune system diseases other than MS
- Active macular edema
- History of selected prior infections and criteria for immunizations
- History of selected immune system treatments and/or medications
- Selected cardiovascular, pulmonary, or hepatic conditions
- Selected abnormal laboratory values
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1053 Patients enrolled
Trial Details
Trial ID
NCT01216072
Start Date
August 1 2010
End Date
August 1 2012
Last Update
February 10 2014
Active Locations (149)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
2
Novartis Investigative Site
Cullman, Alabama, United States, 35058
3
Novartis Investigative Site
Phoenix, Arizona, United States, 85004
4
Novartis Investigative Site
Phoenix, Arizona, United States, 85006