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
Completed · Phase 4
Conditions studied: Relapsing Forms of Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01216072
- Run by
- Novartis Pharmaceuticals
- People needed
- 1053
- Starts
- 2010-08-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2014-02-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Novartis Investigative Site — Fullerton, California, United States
- Novartis Investigative Site — La Habra, California, United States
- Novartis Investigative Site — Loma Linda, California, United States
- Novartis Investigative Site — Newport Beach, California, United States
- Novartis Investigative Site — Oceanside, California, United States
- Novartis Investigative Site — Sacramento, California, United States
- Novartis Investigative Site — Walnut Creek, California, United States
- Novartis Investigative Site — Boulder, Colorado, United States
- Novartis Investigative Site — Colorado Springs, Colorado, United States
- Novartis Investigative Site — Fort Collins, Colorado, United States
- Novartis Investigative Site — Fairfield, Connecticut, United States
- Novartis Investigative Site — New London, Connecticut, United States
- Novartis Investigative Site — Stratford, Connecticut, United States
- Novartis Investigative Site — Dover, Delaware, United States
- Novartis Investigative Site — Newark, Delaware, United States
- Novartis Investigative Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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