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A 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.
Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups: * 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod, * 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or * 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Teplice, Czechia
Novartis Investigative Site
Helsinki, Finland
Novartis Investigative Site
Ostfildern, Baden-Wurttemberg, Germany
Novartis Investigative Site
Celle, Germany, Germany
Novartis Investigative Site
Bad Mergentheim, Germany
Start Date
September 1, 2011
Primary Completion Date
November 1, 2012
Completion Date
November 1, 2012
Last Updated
August 8, 2014
142
ACTUAL participants
Fingolimod
DRUG
Placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT02035514
NCT00787657
Data Source & Attribution
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