Status:
COMPLETED
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-56 years
Phase:
PHASE2
Brief Summary
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 tr...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Patients completed the core study BAF312A2201
- Written informed consent provided before any assessment of the extension study
- Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
Exclusion
- Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
- Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
- Active infections
Key Trial Info
Start Date :
August 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2016
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01185821
Start Date
August 30 2010
End Date
October 10 2016
Last Update
March 27 2018
Active Locations (46)
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1
Novartis Investigative Site
Miami, Florida, United States, 33136
2
Novartis Investigative Site
Pompano Beach, Florida, United States, 33060
3
Novartis Investigative Site
Tallahassee, Florida, United States, 32308
4
Novartis Investigative Site
Chicago, Illinois, United States, 60637