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A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population
This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.
Age
18 - 56 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Pompano Beach, Florida, United States
Novartis Investigative Site
Tallahassee, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Grand Rapids, Michigan, United States
Novartis Investigative Site
Akron, Ohio, United States
Novartis Investigative Site
Greenville, South Carolina, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Gatineau, Quebec, Canada
Start Date
August 30, 2010
Primary Completion Date
October 10, 2016
Completion Date
October 10, 2016
Last Updated
March 27, 2018
185
ACTUAL participants
BAF312
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT04047628
NCT04602390
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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