CompletedPhase 4DMT
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
Sponsored by Novartis Pharmaceuticals
NCT ID
NCT01216072
Target Enrollment
1,053 participants
Start Date
2010-08
Est. Completion
2012-08
About This Study
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 Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.
Conditions Studied
Interventions
- •Fingolimod
- •Standard MS DMTs
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Study Locations (149)
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Cullman, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Berkeley, California, United States
Novartis Investigative Site
Fresno, California, United States
+139 more locations